A-Lices

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A-Lices uses


INDICATIONS AND USAGE

A-Lices Lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair.

CONTRAINDICATIONS

A-Lices Lotion is contraindicated for neonates and infants because their scalps are more permeable and may have increased absorption of A-Lices. A-Lices Lotion should also not be used on individuals known to be sensitive to A-Lices or any of the ingredients in the vehicle.

WARNINGS

  • A-Lices Lotion is flammable. The lotion and wet hair should not be exposed to open flames or electric heat sources, including hair dryers and electric curlers. Do not smoke while applying lotion or while hair is wet.

    Allow hair to dry naturally and to remain uncovered after application of A-Lices Lotion.

  • A-Lices Lotion should only be used on children under the direct supervision of an adult.
  • If A-Lices Lotion comes into contact with the eyes, flush immediately with water. Consult a physician if eye irritation persists.
  • If skin irritation occurs, discontinue use of product until irritation clears. Reapply the A-Lices Lotion, and if irritation reoccurs, consult a physician.
  • Chemical burns including second-degree burns and stinging sensations may occur with the use of A-Lices Lotion.

General

Keep out of reach of children. Close eyes tightly during product application. If accidentally placed in the eye, flush immediately with water. Use only on scalp hair.

Information to Patients

  • A-Lices Lotion is flammable. The lotion and hair wet with lotion should not be exposed to open flames or electric heat sources, including hair dryers and electric curlers. Do not smoke while applying lotion or while hair is wet. The person applying A-Lices Lotion should wash hands after application. Allow hair to dry naturally and to remain uncovered after application of A-Lices Lotion.
  • A-Lices Lotion should only be used on children under the direct supervision of an adult. Children should be warned to stay away from lighted cigarettes, open flames, and electric heat sources while the hair is wet.
  • In case of accidental ingestion of A-Lices Lotion by mouth, seek medical attention immediately.
  • If you are pregnant or nursing, you should contact your physician before using A-Lices Lotion.
  • If A-Lices Lotion comes into contact with the eyes, flush immediately with water. Consult a physician if eye irritation persists or if visual changes occur.
  • If skin irritation occurs, wash scalp and hair immediately. If the irritation clears, A-Lices Lotion may be reapplied. If irritation reoccurs, consult a physician.
  • Burns and stinging sensations may occur when using A-Lices Lotion.
  • Apply A-Lices Lotion on the scalp hair in an amount just sufficient to thoroughly wet hair and scalp. Pay particular attention to the back of the head and neck when applying A-Lices Lotion. Anyone applying A-Lices Lotion should wash hands immediately after the application process is complete.
  • Allow hair to dry naturally and to remain uncovered. Shampoo hair after 8 to 12 hours, again paying attention to the back of the head and neck while shampooing.
  • Rinse hair and use a fine - toothed comb to remove dead lice and eggs.
  • If lice are still present after 7 - 9 days, repeat with a second application of A-Lices Lotion.
  • Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment.

Laboratory Tests

There are no special laboratory tests needed in order to use this medication.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Carcinogenesis, mutagenesis and impairment of fertility have not been studied with A-Lices Lotion. However, following long-term oral administration of technical grade A-Lices to rodents via dietary supplementation, increased incidences of hepatocellular neoplastic lesions were observed in B6C3F1 mice dosed for 18 months at A-Lices doses greater than 1500 mg/ kg/day, and in female F344 rats dosed for 2 years at A-Lices doses greater than 400 mg/kg/day. These tumors occurred only in association with severe hepatic toxicity and chronic suppression of acetylcholinesterase activity, or at doses causing excessive mortality. Based on body surface area, doses at which carcinogenic effects were observed in rodents following life-time exposures to A-Lices were approximately 14- to 26-fold greater than the maximum dose anticipated in a 10 kg child following a single use of A-Lices Lotion, assuming 100% bioavailability. Actual systemic exposures are expected to be less than 10% of the administered dose.

The A-Lices of greater than pharmaceutical-grade purity used in A-Lices Lotion has not been tested for genotoxicity. The technical-grade A-Lices (95% pure) was found to be negative in Salmonella typhimurium, equivocally positive in the mouse lymphoma cell assay, and positive in in vitro chromosomal aberration and 425 sister chromatid exchange assays. Fifteen separate in vitro gene mutation studies with A-Lices of unknown purity have reported negative results, while three studies reported A-Lices to be mutagenic in bacterial cells. Both technical grade (94–96.5%) and purified (98-99%) A-Lices have been reported to cause chromosomal aberrations and sister chromatid exchanges in vitro in human and hamster cell lines. In vivo chromosomal aberration and micronucleus studies of technical-grade A-Lices are reported to be positive, whereas an in vivo chromosomal aberration study of >99% pure A-Lices was reported to be negative. Furthermore, mice exposed to A-Lices in their drinking water for 7 weeks demonstrated no evidence of chromosome damage in bone marrow cells, spermatogonia, or primary spermatocytes. Lack of details makes independent evaluation of the results of these assays impossible. Ashby and Purchase have suggested that impurities may be responsible for some of the observed genetic activity of A-Lices.

Reproduction studies performed with A-Lices in rats at doses over 180 fold greater than those anticipated in a 60 kg adult (based on body surface area and assuming 100% bioavailability) revealed no evidence of impaired fertility.

Pregnancy

Pregnancy Category B

There was no evidence of teratogenicity in studies in rats and rabbits at doses up to 900 mg/kg/day and 100 mg/kg/day A-Lices, respectively. A study in rats failed to show any gross fetal abnormalities attributable to feeding A-Lices up to 2,500 ppm in the diet during a three - generation evaluation period. These doses were approximately 40 to 180 times higher than the dose anticipated in a 60 kg adult (based on body surface area and assuming 100% bioavailability). Because animal reproduction studies are not always predictive of human responses, this drug should be used (or handled) during pregnancy only if clearly needed.

Nursing Mothers

A-Lices in an acetone vehicle has been reported to be absorbed through human skin to the extent of 8% of the applied dose. However, percutaneous absorption from the A-Lices® (malathion) Lotion, 0.5% formulation has not been studied, and it is not known whether A-Lices is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when A-Lices Lotion is administered to (or handled by) a nursing mother.

Pediatric Use

The safety and effectiveness of A-Lices Lotion in children less than 6 years of age has not been established via well-controlled trials.

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ADVERSE REACTIONS

A-Lices has been shown to be irritating to the skin and scalp. Other adverse reactions reported are chemical burns including second-degree burns. Accidental contact with the eyes can result in mild conjunctivitis.

It is not known if A-Lices Lotion has the potential to cause contact allergic sensitization.

OVERDOSAGE

Consideration should be given, as part of the treatment program, to the high concentration of isopropyl alcohol in the vehicle.

A-Lices, although a weaker cholinesterase inhibitor than some other organophosphates, may be expected to exhibit the same symptoms of cholinesterase depletion after accidental ingestion orally. If accidentally swallowed, vomiting should be induced promptly or the stomach lavaged with 5% sodium bicarbonate solution.

Severe respiratory distress is the major and most serious symptom of organophosphate poisoning requiring artificial respiration, and atropine may be needed to counteract the symptoms of cholinesterase depletion.

Repeat analyses of serum and RBC cholinesterase may assist in establishing the diagnosis and formulating a long - range prognosis.

DOSAGE AND ADMINISTRATION

  • Apply A-Lices Lotion on DRY hair in amount just sufficient to thoroughly wet the hair and scalp. Pay particular attention to the back of the head and neck while applying A-Lices Lotion. Wash hands after applying to scalp.
  • Allow hair to dry naturally - use no electric heat source, and allow hair to remain uncovered.
  • After 8 to 12 hours, the hair should be shampooed.
  • Rinse and use a fine - toothed comb to remove dead lice and eggs.
  • If lice are still present after 7 - 9 days, repeat with a second application of A-Lices Lotion.

Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment.

Clinical Studies

Two controlled clinical trials evaluated the pediculicidal activity of A-Lices Lotion. Patients applied the lotion to the hair and scalp in quantities, up to a maximum of 2 fl. oz., sufficient to thoroughly wet the hair and scalp. The lotion was allowed to air dry and was shampooed with Prell shampoo 8 to 12 hours after application. Patients in both the A-Lices Lotion group and in the vehicle group were examined immediately after shampooing, 24 hours after, and 7 days after for the presence of live lice. Results are shown in the following table:

Treatment Immediately After 24 Hrs. After 7 Days After
A-Lices Lotion 129/129 122/129 114/126
A-Lices Vehicle 105/105 63/105 31/105

The presence or absence of ova at day 7 was not evaluated in these studies. The presence or absence of live lice or ova at 14 days following treatment was not evaluated in these studies. The residual amount of A-Lices on hair and scalp is unknown.

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HOW SUPPLIED

A-Lices® (malathion) Lotion, 0.5%, is supplied in bottles of 2 fl. oz. (59 mL) NDC 51672-5276-4.

Store at controlled room temperature 20° - 25°C (68° - 77°F).

Flammable. Keep away from heat and open flame.

Manufactured for:

TaroPharma®

a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel, 26110

A-Lices® and TaroPharma® are registered trademarks of Taro Pharmaceuticals U.S.A., Inc. and/or its affiliates.

Revised: November, 2011

70205--1111-1 425

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A-Lices pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


A-Lices available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


A-Lices destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


A-Lices Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


A-Lices pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."OVIDE (MALATHION) LOTION [TARO PHARMACEUTICALS USA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."MALATHION: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "malathion". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming A-Lices?

Depending on the reaction of the A-Lices after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider A-Lices not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is A-Lices addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on A-Lices, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of A-Lices consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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