Free PLR Content Directory Israel

Thursday, 19 July 2012

Jodid Verla

Jodid Verla may be available in the countries listed below.

Ingredient matches for Jodid Verla

Potassium Iodide

Potassium Iodide is reported as an ingredient of Jodid Verla in the following countries:

Germany

International Drug Name Search

Monday, 16 July 2012

fentanyl citrate oral transmucosal

Generic Name: fentanyl citrate (oral transmucosal) (FEN ta nil SIT rayt)

Brand Names: Actiq

What is fentanyl citrate?

Fentanyl citrate is a narcotic pain medicine.

Fentanyl citrate treats "breakthrough" cancer pain that is not controlled by other medicines. This medication is not for short-term pain relief.

Fentanyl citrate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about fentanyl citrate?

You should not use this medication unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Seek emergency medical attention if you think you have used too much of this medicine or if anyone else has accidentally swallowed it. An overdose of this medicine can be fatal. Overdose symptoms may include weak pulse, fainting, shallow breathing, or breathing that stops. Do not use more than four Actiq units per day.

What should I discuss with my health care provider before taking fentanyl citrate?

You should not use this medication unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Opioid medicines include fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin), hydromorphone (Dilaudid, Palladone), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (Oxycontin), oxymorphone (Numorphan, Opana), and others. Talk with your doctor if you are not sure you are opioid-tolerant.

Do not use fentanyl citrate if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you use fentanyl before the MAO inhibitor has cleared from your body.

You should not use fentanyl citrate if you have had an allergic reaction or severe side effects when using any narcotic pain medicine.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

a breathing disorder such as asthma or chronic obstructive pulmonary disease (COPD);

a seizure disorder;

a history of head injury or brain tumor;

liver or kidney disease;

low blood pressure, heart disease;

a history of depression or other mental illness; or

a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether fentanyl citrate is harmful to an unborn baby. It could cause addiction or withdrawal symptoms in a newborn if the mother uses fentanyl citrate during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Fentanyl citrate can pass into breast milk and may cause sleepiness or breathing problems in a nursing baby. Fentanyl citrate may also cause addiction and withdrawal symptoms in a nursing infant. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more sensitive to the effects of this medicine.

If you are diabetic, you should know that each fentanyl citrate lozenge contains 2 grams (one-half teaspoon) of sugar.

How should I take fentanyl citrate?

Actiq (fentanyl citrate oral transmucosal) comes with a kit and instructions for storing and disposing of the Actiq units. Keep both the used and the unused Actiq units out of the reach of children. The amount of fentanyl citrate in the Actiq unit can be fatal to a child who accidentally sucks on or swallows the unit.

You will also receive instructions for using the medicine. Follow these instructions carefully. Do not use the medication in larger amounts or for longer than prescribed by your doctor. Your doctor may occasionally change your dose to make sure you get the best results.

The Actiq transmucosal unit is a fentanyl citrate lozenge attached to a plastic handle. Each unit is wrapped in a child-proof blister pack. Cut the blister pack open with scissors when you are ready to use the unit.

Place the medicine in your mouth between your cheek and gum, and hold the handle with your fingers. Twirl the handle to move the medicine around in your mouth while sucking on it.

Allow the medicine to dissolve in your mouth for 15 minutes. Swallow when needed. Do not bite or chew the lozenge. Do not eat or drink anything while the unit is in your mouth. If you need to use a second unit, wait at least 15 minutes after you have finished the first unit.

Do not use more than four Actiq units per day.

If you feel dizzy or sick to your stomach before the medicine has completely dissolved, stop using the unit and call your doctor.

If you switch from using Actiq to using other forms of fentanyl, you will not use the same dose. Many forms of fentanyl are given at lower doses than Actiq. If you use the same dose of each medication, you may have life-threatening overdose symptoms. Do not stop using any other pain medicines your doctor has prescribed for you. Call your doctor if fentanyl citrate does not relieve your pain. Do not stop using fentanyl citrate suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using fentanyl citrate. Store at room temperature away from moisture and heat. Leave each unit in its child-proof blister pack until you are ready to use it.

Pay special attention to your dental hygiene. Fentanyl citrate can cause dry mouth leading to tooth decay.

What happens if I miss a dose?

Do not use more than four (4) Actiq units per day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. The amount of fentanyl citrate in the Actiq unit can be fatal to a child who accidentally sucks on or swallows the unit.

Overdose symptoms may include weak pulse, fainting, shallow breathing, or breathing that stops.

What should I avoid while taking fentanyl citrate?

Grapefruit and grapefruit juice may interact with fentanyl and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Fentanyl citrate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using fentanyl citrate and call your doctor at once if you have any of these serious side effects:

shallow breathing, slow heart rate;

extreme sleepiness; or

feeling light-headed, fainting.

Less serious side effects may include:

dry mouth;

headache, dizziness, weakness, anxiety; or

nausea, vomiting, or constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Fentanyl citrate Dosing Information

Usual Adult Dose for Anesthesia:

Premedication for Anesthesia:
50 to 100 mcg IM, 30 to 60 minutes prior to surgery.
Lozenge: 5 mcg/kg (400 mcg is the maximum dose).
Lower doses should be used for vulnerable patients.

General Anesthesia:
Total Low dose: 2 mcg/kg (minor procedures).
Maintenance low dose: Infrequently needed.
Total Moderate dose: 2 to 20 mcg/kg.
Maintenance moderate dose: 25 to 100 mcg IV/IM.
Total high dose: 20 to 50 mcg/kg (prolonged surgeries).
Maintenance high dose: 25 mcg to half of the initial dose.

Adjunct to Regional Anesthesia:
50 to 100 mcg IM or slow IV over 3 to 5 minutes as required.

Postoperative :
50 to 100 mcg IM. May repeat dose in 1 to 2 hours as needed.

Usual Adult Dose for Pain:

Transdermal patch - Initial dose: 25 mcg/hour patch (unless opioid tolerance) every 72 hours.

Transmucosal - Initial dose: 200 mcg, place in mouth (between cheek and lower gum) and suck over 15 minutes (do not chew or swallow).

Fentanyl iontophoretic transdermal system - Patients should be titrated to comfort before initiating the fentanyl iontophoretic transdermal system. Fentanyl iontophoretic transdermal system should be applied to intact, nonirritated, nonirradiated skin on the chest or upper outer arm.

Patients must have access to supplemental analgesia during treatment with the fentanyl iontophoretic transdermal system. Fentanyl iontophoretic transdermal system provides a 40 mcg dose of fentanyl per activation on-demand. It is important to instruct patients how to operate fentanyl iontophoretic transdermal system to self-administer doses of fentanyl as needed to manage their acute, short-term, postoperative pain. Only the patient should administer doses from fentanyl iontophoretic transdermal system. Each on-demand dose is delivered over a 10-minute period. To initiate administration of a fentanyl dose, the patient must press the button firmly twice within 3 seconds. An audible tone (beep) indicates the start of delivery of each dose; the red light remains on throughout the 10 minute dosing period.

Patients on chronic opioid therapy or with a history of opioid abuse may require higher analgesic doses in the postoperative period than are available from fentanyl iontophoretic transdermal system. Therefore, these patients should be evaluated frequently to ensure they are receiving adequate analgesia.

A maximum of six 40 mcg doses per hour can be administered by fentanyl iontophoretic transdermal system. The maximum amount of fentanyl that can be administered from a single fentanyl iontophoretic transdermal system over 24 hours is 3.2 mg (eighty 40 mcg doses). Each fentanyl iontophoretic transdermal system operates for 24 hours or until eighty doses have been administered, whichever occurs first. Up to three consecutive fentanyl iontophoretic transdermal systems may be used sequentially, each applied to a different skin site for a maximum of 72 hours of therapy for acute, short-term, postoperative pain.

Buccal Tablet
Initial Dose: 100 mcg.
Dose Titration: Patients should be titrated to a dose of fentanyl buccal tablet that provides adequate analgesia with tolerable side effects.

For patients switching from oral transmucosal fentanyl citrate to fentanyl buccal tablet, the starting dose of fentanyl buccal tablet should be as follows. An oral transmucosal fentanyl citrate dose of 200 mcg or 400 mcg converts to an initial fentanyl buccal tablet dose of 100 mcg. An oral transmucosal fentanyl citrate dose of 600 or 800 mcg converts to an initial fentanyl buccal tablet dose of 200 mcg. And, an oral transmucosal fentanyl citrate dose of 1200 mcg or 1600 mcg converts to an initial fentanyl buccal tablet dose of 400 mcg.

Redosing Patients Within a Single Episode: Dosing may be repeated once during a single episode of breakthrough pain if pain is not adequately relieved by one fentanyl buccal tablet dose. Redosing may occur 30 minutes after the start of administration of fentanyl buccal tablet and the same dosage strength should be used.

Buccal soluble film:
For use only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain:

The goal of dose titration is to find the individual patient's effective and tolerable dose. The dose of fentanyl buccal soluble film is not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain and must be determined by dose titration.

Individually titrate fentanyl buccal soluble film to a dose that provides adequate analgesia with tolerable side effects.

Initial dose: All patients must begin treatment using one 200 mcg fentanyl buccal soluble film. Due to differences in pharmacokinetic properties and individual variability, patients switching from another oral transmucosal fentanyl product must be started on no greater than 200 mcg of fentanyl buccal soluble film. When prescribing, do not switch patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to fentanyl buccal soluble film as fentanyl buccal soluble film is not equivalent on a mcg per mcg basis with any other fentanyl product. Fentanyl buccal soluble film is not a generic version of any other oral transmucosal fentanyl product.

Following the initial dose, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia. If adequate pain relief is not achieved after one 200 mcg fentanyl buccal soluble film, titrate using multiples of the 200 mcg fentanyl buccal soluble film (for doses of 400, 600, or 800 mcg). Increase the dose by 200 mcg in each subsequent episode until the patient reaches a dose that provides adequate analgesia with tolerable side effects. Do not use more than four of the 200 mcg fentanyl buccal soluble film simultaneously. When multiple 200 mcg fentanyl buccal soluble films are used, they should not be placed on top of each other and may be placed on both sides of the mouth.

If adequate pain relief is not achieved after 800 mcg fentanyl buccal soluble film (i.e., four 200 mcg fentanyl buccal soluble films), and the patient has tolerated the 800 mcg dose, treat the next episode by using one 1200 mcg fentanyl buccal soluble film. Doses above 1200 mcg fentanyl buccal soluble film should not be used.

The patient should then get a prescription for fentanyl buccal soluble film of the dose determined by titration (i.e., 200, 400, 600, 800, or 1200 mcg) to treat subsequent episodes.

Single doses should be separated by at least 2 hours. Fentanyl buccal soluble film should only be used once per breakthrough cancer pain episode, i.e., fentanyl buccal soluble film should not be redosed within an episode.

During any episode of breakthrough cancer pain, if adequate pain relief is not achieved from use of fentanyl buccal soluble film, the patient may use a rescue medication (after 30 minutes) as directed by their healthcare provider.

During maintenance treatment, if the prescribed dose no longer adequately manages the breakthrough cancer pain episode for several consecutive episodes, increase the dose of fentanyl buccal soluble film. Once a successful dose has been found, each episode is treated with a single film. Fentanyl buccal soluble film should be limited to four or fewer doses per day. Consider increasing the dose of the around-the-clock opioid medicine used for persistent cancer pain in patients experiencing more than four breakthrough cancer pain episodes daily.

The tongue should be used to wet the inside of the cheek or rinse the mouth with water to wet the area for placement of fentanyl buccal soluble film. The fentanyl buccal soluble film package should be opened immediately prior to product use. Place the entire fentanyl buccal soluble film near the tip of a dry finger with the pink side facing up and hold in place. Place the pink side of the fentanyl buccal soluble film against the inside of the cheek. Press and hold the fentanyl buccal soluble film in place for five seconds. The fentanyl buccal soluble film should stay in place on its own after this period. Liquids may be consumed after five minutes. Fentanyl buccal soluble film, if chewed and swallowed, might result in lower peak concentrations and lower bioavailability than when used as directed.

The fentanyl buccal soluble film should not be cut or torn prior to use. The fentanyl buccal soluble film will dissolve within 15 to 30 minutes after application. The film should not be manipulated with the tongue or finger(s). Eating food should be avoided until the film has dissolved.

Sublingual tablets:
For use only for the management of breakthrough pain in patients with cancer who are 18 years of age and older and who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking pain relief medication around-the-clock of at least 60 mg of oral morphine daily, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or at least 25 mg oral oxymorphone daily, or an equal dose of another opioid medication daily for 7 days or more.

The goal of dose titration is to find the effective and tolerable dose for the individual patient. The dose of fentanyl sublingual is not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain and must be determined by dose titration.

Fentanyl sublingual tablets should be placed on the floor of the mouth directly under the tongue immediately after removal from the packaging. The patient should be instructed not to chew, suck, or swallow the sublingual tablet. Patients should not eat or drink anything until the tablet is completely dissolved. Water may be used to moisten the buccal mucosa before taking fentanyl sublingual in patients who have a dry mouth.

Initial dose: All patients must begin treatment with a single 100 mcg sublingual tablet. Due to differences in pharmacokinetic properties and individual variability, patients switching from another fentanyl product must be started on the 100 mcg sublingual dose. Patients should not be switched on a mcg per mcg basis from any other fentanyl product to fentanyl sublingual as fentanyl sublingual is not equivalent on a mcg per mcg basis with any other fentanyl product. Fentanyl sublingual is not a generic version of any other fentanyl product. Following the initial dose, patients should be followed closely and the dosage level adjusted until the patient reaches a dose that provides adequate analgesia. If adequate analgesia is obtained within 30 minutes of administration of the 100 mcg tablet, continue to treat subsequent episodes of breakthrough pain with this dose. If adequate pain relief is not achieved after one 100 mcg tablet, the patient may take a second dose (after 30 minutes). No more than 2 doses may be used to treat one episode of breakthrough pain. Patients must wait at least 2 hours after the last dose to treat another episode of breakthrough pain.

Titration: If adequate pain relief is not achieved after the first 100 mcg dose, the dose should be increased in a stepwise manner over consecutive breakthrough pain episodes until adequate analgesia with tolerable side effects is achieved. The dose should be increased by 100 mcg multiples up to 400 mcg if needed. If adequate analgesia is not obtained with a 400 mcg dose, increase to 600 mcg. If adequate analgesia is not obtained with a 600 mcg dose, increase to 800 mcg. During titration, patients can be instructed to use multiples of 100 mcg tablets and/or 200 mcg tablets for any single dose. Patients should not use more than 4 tablets at one time. If adequate analgesia is not obtained 30 minutes after use, the patient may repeat the same dose. No more than two doses of may be used to treat an episode of breakthrough pain. Rescue medication as directed by the healthcare provider may be used if adequate analgesia is not achieved.

The efficacy and safety of doses higher than 800 mcg have not been evaluated in clinical studies.

Maintenance: Once an appropriate dose for pain management has been established, patients should be instructed to use only one tablet of the appropriate strength per dose. Patients should be maintained on this dose. If adequate analgesia is not obtained, the patient may use a second dose (after 30 minutes) as directed by their health care provider. No more than two doses may be used to treat an episode of breakthrough pain. Patients must wait at least 2 hours before treating another episode of breakthrough pain.

Dose readjustment: If the response (analgesia or adverse reactions) to the titrated dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained.

If more than four episodes of breakthrough pain are experienced daily, the dose of the long-acting opioid used for persistent underlying cancer pain should be reevaluated. If the long-acting opioid or dose of long-acting opioid is changed, the fentanyl sublingual dose should be retitrated as necessary to ensure the patient is on an appropriate dose.

The use of fentanyl sublingual should be limited to treat four or fewer episodes of breakthrough pain per day.

It is important that any dose retitration is monitored carefully by a healthcare professional.

Discontinuation: Patients no longer requiring opioid therapy may discontinue fentanyl sublingual along with a gradual downward titration of other opioids to minimize possible withdrawal effects. Patients who continue to take chronic opioid therapy for chronic pain but no longer need treatment for breakthrough pain may discontinue fentanyl sublingual immediately.

Fentanyl nasal spray:
For use only for the management of breakthrough pain in patients with cancer who are 18 years of age and older and who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain.

Fentanyl nasal spray should be titrated to a dose that provides adequate analgesia with tolerable side effects.
Initial dose: Treatment of all patients (including those switching from another fentanyl product) should be initiated with 1 spray into 1 nostril.

Maintenance dose: If adequate analgesia is achieved within 30 minutes of administration of 1 spray in 1 nostril, subsequent episodes of breakthrough pain may be treated with this dose. If adequate analgesia is not achieved with the first dose, the dose should be escalated in a step wise manner over consecutive episodes of breakthrough pain until adequate analgesia with tolerable side effects is achieved.

Titration: Patients must wait at least 2 hours between doses:
Step 1: 1 spray (100 mcg per spray) into 1 nostril (100 mcg)
Step 2: 1 spray (100 mcg per spray) into each nostril (200 mcg)
Step 3: 1 spray (400 mcg per spray) into 1 nostril (400 mcg)
Step 4: 1 spray (400 mcg per spray) into each nostril (800 mcg)

Maximum dose: 800 mcg per episode of breakthrough pain no more often than every 2 hours and no more than 4 doses per day.

During any episode of breakthrough cancer pain, if there is inadequate pain relief after 30 minutes following fentanyl nasal spray dosing or if a separate episode of breakthrough cancer pain occurs before the next dose is permitted (i.e., within 2 hours), the healthcare provider should be prepared to offer the patient another medication for rescue.

There are no clinical data to support the use of a combination of dose strengths to treat an episode.

Usual Pediatric Dose for Anesthesia:

Doses should be titrated to appropriate effects; wide range of doses exist, dependent upon desired degree of analgesia/anesthesia, clinical environment, patient's status, and presence of opioid tolerance.

Neonates: Analgesia: International Evidence-Based Group for Neonatal Pain recommendations:
Intermittent doses: Slow IV push: 0.5 to 3 mcg/kg/dose
---Continuous IV infusion: 0.5 to 2 mcg/kg/hour
---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward
---Mean required dose: Neonates with gestational age less than 34 weeks: 0.64 mcg/kg/hour; neonates with gestational age greater than or equal to 34 weeks: 0.75 mcg/kg/hour
---Continuous sedation/analgesia during extracorporeal membrane oxygenation (ECMO): Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO.

Younger infants:
---Sedation/analgesia: Slow IV push: 1 to 4 mcg/kg/dose; may repeat every 2 to 4 hours
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg, then 0.5 to 1 mcg/kg/hour; titrate upward
---Continuous sedation/analgesia during extracorporeal membrane oxygenation ECMO: Initial IV bolus: 5 to 10 mcg/kg slow IV push over 10 minutes, then 1 to 5 mcg/kg/hour; titrate upward; tolerance may develop; higher doses (up to 20 mcg/kg/hour) may be needed by day 6 of ECMO.

Older Infants and Children 1 to 12 years:
---Sedation for minor procedures/analgesia: IM or IV: 1 to 2 mcg/kg/dose; may repeat at 30 to 60 minute intervals. Note: Children 18 to 36 months of age may require 2 to 3 mcg/kg/dose.
--- Intranasal: Children greater than or equal to 10 kg: 1.5 mcg/kg once (maximum: 100 mcg/dose); reported range: 1 to 2 mcg/kg; some studies allowed for additional incremental doses of 0.5 mcg/kg to be administered every 5 minutes, not to exceed a total dose of 3 mcg/kg depending on pain type and severity.
---Continuous sedation/analgesia: Initial IV bolus: 1 to 2 mcg/kg then 1 mcg/kg/hour; titrate upward; usual: 1 to 3 mcg/kg/hour; some require 5 mcg/kg/hour
---Moderate to severe chronic pain: Transdermal patch: Opioid-tolerant children greater than or equal to 2 years receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to fentanyl equivalents and administration of equianalgesic dosage (see package insert for further information); use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days, based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; change patch every 72 hours; Note: Dosing intervals less than every 72 hours are not recommended for children and adolescents. Initiation of the transdermal patch in children taking less than 60 mg of oral morphine equivalents per day has not been studied in controlled clinical trials; in open-label trials, children 2 to 18 years of age who were receiving at least 45 mg of oral morphine equivalents per day were started with an initial transdermal dose of 25 mcg/hour (or higher, depending upon equianalgesic dose of opioid received).

Children greater than or equal to 5 years and less than 50 kg:
Patient-controlled analgesia (PCA): IV: Opioid-naive: Note: PCA has been used in children as young as 5 years of age; however, clinicians need to assess children 5 to 8 years of age to determine if they are able to use the PCA device correctly. All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed.

Usual concentration: Determined by weight; some clinicians use the following:
---Children less than 12 kg: 10 mcg/mL
---Children 12 to 30 kg: 25 mcg/mL
---Children greater than 30 kg: 50 mcg/mL
---Demand dose: Usual initial: 0.5 to 1 mcg/kg/dose; usual range: 0.5 to 1 mcg/kg/dose
---Lockout: Usual initial: 5 doses/hour
---Lockout interval: Range: 6 to 8 minutes
---Usual basal rate: 0 to 0.5 mcg/kg/hour

Children greater than 12 years to adult:
Sedation for minor procedures/analgesia: IV: 0.5 to 1 mcg/kg/dose; may repeat after 30 to 60 minutes; or 25 to 50 mcg, repeat full dose in 5 minutes if needed, may repeat 4 to 5 times with 25 mcg at 5 minute intervals if needed. Note: Higher doses are used for major procedures.

Continuous sedation/analgesia:
---Less than 50 kg: Initial IV bolus: 1 to 2 mcg/kg; continuous infusion rate: 1 to 2 mcg/kg/hour
---Greater than 50 kg: Initial IV bolus: 1 to 2 mcg/kg or 25 to 100 mcg/dose; continuous infusion rate: 1 to 2 mcg/kg/hour or 25 to 200 mcg/hour

Patient-controlled analgesia (PCA): IV: Children greater than 50 kg, Adolescents greater than 50 kg, and Adults: Note: All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed:

---Usual concentration: 50 mcg/mL
---Demand dose: Usual initial: 20 mcg; usual range: 10 to 50 mcg
---Lockout interval: Usual initial: 6 minutes; usual range: 5 to 8 minutes
---Usual basal rate: less than or equal to 50 mcg/hour

Preoperative sedation, adjunct to regional anesthesia, postoperative pain: IM, IV: 25 to 100 mcg/dose

Adjunct to general anesthesia: Slow IV:
---Low dose: 0.5 to 2 mcg/kg/dose depending on the indication
---Moderate dose: Initial: 2 to 20 mcg/kg/dose; Maintenance (bolus or infusion): 1 to 2 mcg/kg/hour. Discontinuing fentanyl infusion 30 to 60 minutes prior to the end of surgery will usually allow adequate ventilation upon emergence from anesthesia. For "fast-tracking" and early extubation following major surgery, total fentanyl doses are limited to 10 to 15 mcg/kg.
---High dose: 20 to 50 mcg/kg/dose; Note: High dose fentanyl as an adjunct to general anesthesia is rarely used, but is still described in the manufacturer label.

General anesthesia without additional anesthetic agents: IV: 50 to 100 mcg/kg with oxygen and skeletal muscle relaxant

Moderate to severe chronic pain: Transdermal patch: Opioid tolerant patients receiving at least 60 mg oral morphine equivalents per day: Initial: 25 mcg/hour system or higher, based on conversion to fentanyl equivalents and administration of equianalgesic dosage (see package insert for further information); use short-acting analgesics for first 24 hours with supplemental PRN doses thereafter (for breakthrough pain); dose may be increased after 3 days based on the daily dose of supplementary PRN opioids required; use the ratio of 45 mg of oral morphine equivalents per day to a 12.5 mcg/hour increase in transdermal patch dosage; transdermal patch is usually administered every 72 hours but select adult patients may require every 48-hour administration; dosage increase administered every 72 hours should be tried before 48-hour schedule is used.

Adolescents greater than or equal to 16 years to adult: Breakthrough cancer pain: Transmucosal lozenge: Opioid-tolerant patients: Titrate dose to provide adequate analgesia: Initial: 200 mcg; may repeat dose only once, 15 minutes after completion of first dose if needed. Do not exceed a maximum of 2 doses per each breakthrough cancer pain episode; patient must wait at least 4 hours before treating another episode. Titrate dose up to next higher strength if treatment of several consecutive breakthrough episodes requires more than 1 lozenge per episode; evaluate each new dose over several breakthrough cancer pain episodes (generally 1 to 2 days) to determine proper dose of analgesia with acceptable side effects. Once the dose has been determined, consumption should be limited to less than or equal to 4 units/day. Reevaluate maintenance (around-the-clock) opioid dose if patient requires more than 4 units/day. If signs of excessive opioid effects occur before a dose is complete, the unit should be removed from the mouth immediately, and subsequent doses decreased.

Usual Pediatric Dose for Pain:

Usual Pediatric Dose for Sedation:

Monday, 9 July 2012

Rinstead Sugar Free Pastilles

1. Name Of The Medicinal Product

Rinstead Sugar Free Pastilles

2. Qualitative And Quantitative Composition

Menthol BP 0.033% w/w

Cetylpyridinium chloride BP 0.128% w/w

3. Pharmaceutical Form

Pastille.

4. Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of pain and discomfort from recurrent mouth ulcers and denture sore spots.

4.2 Posology And Method Of Administration

Adults and children over 12 years:

Allow one pastille to dissolve slowly in the mouth about every two hours.

4.3 Contraindications

Hypersensitivity to cetylpyridinium chloride or menthol or to any component of the formulation.

4.4 Special Warnings And Precautions For Use

If symptoms persist, a physician or dentist should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

The safety of Rinstead Sugar Free Pastilles in pregnancy and lactation has not been established. Therefore, this product should only be used in pregnancy when considered essential by a physician.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Sensitisation to the product is a possible undesirable effect.

4.9 Overdose

If overdose is suspected, this should be treated symptomatically with gastric lavage and supportive therapy, if indicated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Menthol, applied locally in low concentrations, provides a soothing effect.

Cetylpyridinium chloride is an antiseptic, active against a wide spectrum of micro-organisms.

5.2 Pharmacokinetic Properties

Menthol is excreted in the urine and bile as a glucuronide.

Cetylpyridinium chloride is poorly absorbed and is excreted mainly via the faeces.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tartaric acid

Amaranth, Rinstead Oils

Sodium ricinoleate (50% sln)

Acesulfame potassium

Acacia gum

Sorbitol

Silicone Antifoam

Vegetable Oil

Beeswax

Water

6.2 Incompatibilities

None known

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

Aluminium foil/clear PVC blister strips contained in a cardboard carton. Pack sizes of 12, 24, 30, 36 and 48 pastilles.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

8. Marketing Authorisation Number(S)

PL 00025/0586

9. Date Of First Authorisation/Renewal Of The Authorisation

16 April 1996 / 16 April 2001

10. Date Of Revision Of The Text

22 January 2011

11. LEGAL CATEGORY

GSL

Rinstead SFP/01-11/02

Sunday, 8 July 2012

Folbecal

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Folbecal (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Prenatal vitamins side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;

headache; or

unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Folbecal resources

Folbecal Side Effects (in more detail)
Folbecal Use in Pregnancy & Breastfeeding
Folbecal Drug Interactions
Folbecal Support Group
0 Reviews for Folbecal - Add your own review/rating

Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)

Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)

CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal Assure Prescribing Information (FDA)

CitraNatal Harmony Prescribing Information (FDA)

Concept DHA Prescribing Information (FDA)

Docosavit Prescribing Information (FDA)

Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)

Folcal DHA Prescribing Information (FDA)

Folcaps Care One Prescribing Information (FDA)

Gesticare DHA Prescribing Information (FDA)

Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)

Inatal Advance Prescribing Information (FDA)

Inatal Ultra Prescribing Information (FDA)

Multi-Nate DHA Prescribing Information (FDA)

Multi-Nate DHA Extra Prescribing Information (FDA)

MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)

Natelle One Prescribing Information (FDA)

Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)

Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)

OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)

Paire OB Plus DHA Prescribing Information (FDA)

PreNexa Prescribing Information (FDA)

PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)

PreferaOB Prescribing Information (FDA)

Prenatal Plus Prescribing Information (FDA)

Prenatal Plus Iron Prescribing Information (FDA)

Prenate Elite Prescribing Information (FDA)

Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)

Prenate Elite tablets

Prenate Essential Prescribing Information (FDA)

PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)

PrimaCare ONE capsules

PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)

Renate DHA Prescribing Information (FDA)

Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Se-Natal 19 Prescribing Information (FDA)

Tandem DHA Prescribing Information (FDA)

Tandem OB Prescribing Information (FDA)

TriAdvance Prescribing Information (FDA)

Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)

Triveen-PRx RNF Prescribing Information (FDA)

UltimateCare ONE NF Prescribing Information (FDA)

Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)

Vinate AZ Prescribing Information (FDA)

Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)

Zatean-CH Prescribing Information (FDA)

Compare Folbecal with other medications

Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

Your pharmacist can provide more information about prenatal vitamins.

See also: Folbecal side effects (in more detail)

flurandrenolide Topical application

flur-an-DREN-oh-lide

Commonly used brand name(s)

In the U.S.

Cordran

Cordran SP

Cordran Tape

In Canada

Drenison

Drenison 1/4

Drenison Tape

Available Dosage Forms:

Lotion

Ointment

Tape

Cream

Therapeutic Class: Corticosteroid, Strong

Pharmacologic Class: Adrenal Glucocorticoid

Uses For flurandrenolide

Flurandrenolide topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. Flurandrenolide tape is used for dry and scaling skin lesions. flurandrenolide is a corticosteroid (cortisone-like medicine or steroid).

flurandrenolide is available only with your doctor's prescription.

Before Using flurandrenolide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For flurandrenolide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to flurandrenolide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of flurandrenolide topical in the pediatric population. However, because of flurandrenolide's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using flurandrenolide, follow your doctor's instructions very carefully.

Geriatric

No information is available on the relationship of age to the effects of flurandrenolide topical in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of flurandrenolide

It is very important that you use flurandrenolide only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

flurandrenolide is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

flurandrenolide should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. flurandrenolide should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Wash your hands with soap and water before and after using flurandrenolide.

Do not use the lotion on the face, groin, or underarms unless directed to do so by your doctor.

Do not use the tape in an area where the skin folds together (e.g. between the fingers).

To use the cream, lotion, or ointment:

Shake the lotion well before using.

Apply a thin layer of flurandrenolide to the affected area of the skin. Rub it in gently.

With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried.

Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.

If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

To use the tape:

flurandrenolide comes with patient directions. Read and follow the instructions carefully.

Gently clean and wash the affected area with soap and water.

Shave or clip the hair in the affected area to allow good application on the skin and comfortable removal of the tape.

If you bathe or shower before applying flurandrenolide, make sure that the area to be covered is completely dry.

Measure and cut the tape to be used on the affected area. Do not tear or break the tape.

Pull the white paper from the transparent tape. Be careful that the tape does not stick to itself.

Apply and press the tape gently on the skin.

Replace the tape every 12 hours, unless otherwise directed by your doctor. Clean and wash the skin. Allow it to dry for 1 hour before applying a new tape.

Dosing

The dose of flurandrenolide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of flurandrenolide. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For redness, itching, and swelling of the skin:
- For topical dosage forms (cream, lotion, and ointment):
  - Adults—Apply to the affected area of the skin two or three times per day.
  - Children—Use and dose must be determined by your doctor.
- For topical dosage form (tape):
  - Adults—Apply to the affected area of the skin every 12 hours.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of flurandrenolide, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using flurandrenolide

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by flurandrenolide. Blood and urine tests may be needed to check for unwanted effects.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of flurandrenolide or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using flurandrenolide: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using flurandrenolide and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

flurandrenolide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Blistering, burning, crusting, dryness, or flaking of the skin

irritation

itching, scaling, severe redness, soreness, or swelling of the skin

redness and scaling around the mouth

thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Acne or pimples

burning and itching of the skin with pinhead-sized red blisters

burning, itching, and pain in hairy areas, or pus at the root of the hair

increased hair growth on the forehead, back, arms, and legs

lightening of normal skin color

lightening of the treated areas of dark skin

reddish purple lines on the arms, face, legs, trunk, or groin

softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: flurandrenolide Topical application side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Compare flurandrenolide Topical application with other medications

Atopic Dermatitis
Dermatitis
Eczema
Psoriasis

Saturday, 7 July 2012

Permethrin

Permethrin Cream, 5%*

*W/W

Rx Only

Permethrin Description

Permethrin Cream, 5% is a topical scabicidal agent for the treatment of infestation with Sarcoptes scabiei (scabies). It is available in an off-white, vanishing cream base. Permethrin Cream, 5% is for topical use only.

Chemical Name – The Permethrin used is an approximate 1:3 mixture of the cis and trans isomers of the pyrethroid 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylic acid, (3-phenoxyphenyl) methyl ester. Permethrin has a molecular formula of C21H20Cl2O3 and a molecular weight of 391.29. It is a yellow to light orange-brown, low melting solid or viscous liquid.

Active Ingredient – Each gram contains Permethrin 50 mg (5%).

Inactive Ingredients – Butylated hydroxytoluene, carbomer homopolymer type B, fractionated coconut oil, glycerin, glyceryl monostearate, isopropyl myristate, lanolin alcohols, mineral oil, polyoxyethylene cetyl ethers, purified water, and sodium hydroxide. Formaldehyde 1 mg (0.1%) is added as a preservative.

Permethrin - Clinical Pharmacology

Permethrin, a pyrethroid, is active against a broad range of pests including lice, ticks, fleas, mites, and other arthropods. It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization and paralysis of the pests are the consequences of this disturbance.

Permethrin is rapidly metabolized by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. Although the amount of Permethrin absorbed after a single application of the 5% cream has not been determined precisely, data from studies with 14C-labeled Permethrin and absorption studies of the cream applied to patients with moderate to severe scabies indicate it is 2% or less of the amount applied.

Indications and Usage for Permethrin

Permethrin Cream, 5% is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).

Contraindications

Permethrin Cream, 5% is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.

Warnings

If hypersensitivity to Permethrin Cream, 5% occurs, discontinue use.

Precautions

General

Scabies infestation is often accompanied by pruritus, edema, and erythema. Treatment with Permethrin Cream, 5% may temporarily exacerbate these conditions.

Information for Patients

Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of Permethrin Cream, 5%. In clinical trials, approximately 75% of patients treated with Permethrin cream, 5% who continued to manifest pruritus at 2 weeks had cessation by 4 weeks. If irritation persists, they should consult their physician. Permethrin Cream, 5% may be very mildly irritating to the eyes. Patients should be advised to avoid contact with eyes during application and to flush with water immediately if Permethrin Cream, 5% gets in the eyes.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Six carcinogenicity bioassays were evaluated with Permethrin, three each in rats and mice. No tumorigenicity was seen in the rat studies. However, species-specific increases in pulmonary adenomas, a common benign tumor of mice of high spontaneous background incidence, were seen in the three mouse studies. In one of these studies there was an increased incidence of pulmonary alveolar-cell carcinomas and benign liver adenomas only in female mice when Permethrin was given in their food at a concentration of 5000 ppm. Mutagenicity assays, which give useful correlative data for interpreting results from carcinogenicity bioassays in rodents, were negative. Permethrin showed no evidence of mutagenic potential in a battery of in vitro and in vivo genetic toxicity studies.

Permethrin did not have any adverse effect on reproductive function at a dose of 180 mg/kg/day orally in a three-generation rat study.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies have been performed in mice, rats, and rabbits (200 to 400 mg/kg/day orally) and have revealed no evidence of impaired fertility or harm to the fetus due to Permethrin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the evidence for tumorigenic potential of Permethrin in animal studies, consideration should be given to discontinuing nursing temporarily or withholding the drug while the mother is nursing.

Pediatric Use

Permethrin Cream, 5% is safe and effective in pediatric patients two months of age and older. Safety and effectiveness in infants less than two months of age have not been established.

Geriatric Use

Clinical studies of Permethrin cream, 5% did not identify sufficient numbers of subjects aged 65 and over to allow a definitive statement regarding whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney. However, since topical Permethrin is metabolized in the liver and excreted in the urine as inactive metabolites, there does not appear to be an increased risk of toxic reactions in patients with impaired renal function when used as labeled.

Adverse Reactions

In clinical trials, generally mild and transient burning and stinging followed application with Permethrin cream, 5% in 10% of patients and was associated with the severity of infestation. Pruritus was reported in 7% of patients at various times post-application. Erythema, numbness, tingling, and rash were reported in 1 to 2% or less of patients (see ). Other adverse events reported since marketing Permethrin cream, 5% include: headache, fever, dizziness, abdominal pain, diarrhea and nausea and/or vomiting. Although extremely uncommon and not expected when used as directed (see ), rare occurrences of seizure have been reported. None have been medically confirmed as associated with Permethrin Cream, 5% treatment.

Overdosage

No instance of accidental ingestion of Permethrin Cream, 5% has been reported. If ingested, gastric lavage and general supportive measures should be employed. Excessive topical use (see DOSAGE AND ADMINISTRATION) may result in increased irritation and erythema.

Permethrin Dosage and Administration

Adults and children

Thoroughly massage Permethrin Cream, 5% into the skin from the head to the soles of the feet. Scabies rarely infests the scalp of adults, although the hairline, neck, temple, and forehead may be infested in infants and geriatric patients. Usually 30 grams is sufficient for an average adult. The cream should be removed by washing (shower or bath) after 8 to 14 hours. Infants should be treated on the scalp, temple, and forehead. ONE APPLICATION IS GENERALLY CURATIVE.

Patients may experience persistent pruritus after treatment. This is rarely a sign of treatment failure and is not an indication for retreatment. Demonstrable living mites after 14 days indicate that retreatment is necessary.

How is Permethrin Supplied

Permethrin Cream, 5% (w/w) is available as follows:

60 g tube (NDC 45802-269-37)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Manufactured by Perrigo

Bronx, NY 10457

Distributed By

PERRIGO®

Allegan, MI 49010

www.perrigo.com

Rev. 10/10

1T600 RC J3

Principal Display Panel - Carton

Rx Only

Permethrin Cream, 5%*

*w/w

For External Use Only. Not for Use In Eyes.

Permethrin Cream, 5%* Carton

Principal Display Panel - Tube

Rx Only

Permethrin Cream, 5%*

*w/w

For External Use Only. Not for Use In Eyes.

Permethrin Cream, 5%* Tube

Permethrin
Permethrin cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	45802-269
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Permethrin (Permethrin)	Permethrin	50 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE
CARBOMER HOMOPOLYMER TYPE B
MEDIUM-CHAIN TRIGLYCERIDES
GLYCERIN
GLYCERYL MONOSTEARATE
ISOPROPYL MYRISTATE
LANOLIN ALCOHOLS
MINERAL OIL
WATER
SODIUM HYDROXIDE
CETETH-20
FORMALDEHYDE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	45802-269-37	1 TUBE In 1 CARTON	contains a TUBE
1		60 g In 1 TUBE	This package is contained within the CARTON (45802-269-37)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076369	08/11/2006

Labeler - Perrigo New York Inc (078846912)

Revised: 06/2010Perrigo New York Inc

More Permethrin resources

Permethrin Side Effects (in more detail)
Permethrin Use in Pregnancy & Breastfeeding
Permethrin Support Group
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Acticin Topical Advanced Consumer (Micromedex) - Includes Dosage Information

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Head Lice
Lice
Scabies

Thursday, 19 July 2012

Jodid Verla

Ingredient matches for Jodid Verla

Monday, 16 July 2012

fentanyl citrate oral transmucosal

What is fentanyl citrate?

What is the most important information I should know about fentanyl citrate?

What should I discuss with my health care provider before taking fentanyl citrate?

How should I take fentanyl citrate?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking fentanyl citrate?

Fentanyl citrate side effects

Fentanyl citrate Dosing Information

Monday, 9 July 2012

Rinstead Sugar Free Pastilles

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

8. Marketing Authorisation Number(S)

9. Date Of First Authorisation/Renewal Of The Authorisation

10. Date Of Revision Of The Text

Sunday, 8 July 2012

Folbecal

What are Folbecal (prenatal multivitamins)?

What is the most important information I should know about prenatal vitamins?

What should I discuss with my healthcare provider before taking prenatal vitamins?

How should I take prenatal vitamins?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking prenatal vitamins?

Prenatal vitamins side effects

What other drugs will affect prenatal vitamins?

More Folbecal resources

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Where can I get more information?

flurandrenolide Topical application

Commonly used brand name(s)

Uses For flurandrenolide

Before Using flurandrenolide

Allergies

Pediatric

Geriatric

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of flurandrenolide

Dosing

Missed Dose

Storage

Precautions While Using flurandrenolide

flurandrenolide Side Effects

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Saturday, 7 July 2012

Permethrin

Permethrin Description

Permethrin - Clinical Pharmacology