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DRUGS & SUPPLEMENTS
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What is the dose of the medication you are taking? |
Quellada-M Lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair.
Quellada-M Lotion is contraindicated for neonates and infants because their scalps are more permeable and may have increased absorption of Quellada-M. Quellada-M Lotion should also not be used on individuals known to be sensitive to Quellada-M or any of the ingredients in the vehicle.
Allow hair to dry naturally and to remain uncovered after application of Quellada-M Lotion.
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.
There are no special laboratory tests needed in order to use this medication.
Carcinogenesis, mutagenesis and impairment of fertility have not been studied with Quellada-M Lotion. However, following long-term oral administration of technical grade Quellada-M to rodents via dietary supplementation, increased incidences of hepatocellular neoplastic lesions were observed in B6C3F1 mice dosed for 18 months at Quellada-M doses greater than 1500 mg/ kg/day, and in female F344 rats dosed for 2 years at Quellada-M 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 Quellada-M were approximately 14- to 26-fold greater than the maximum dose anticipated in a 10 kg child following a single use of Quellada-M Lotion, assuming 100% bioavailability. Actual systemic exposures are expected to be less than 10% of the administered dose.
The Quellada-M of greater than pharmaceutical-grade purity used in Quellada-M Lotion has not been tested for genotoxicity. The technical-grade Quellada-M (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 Quellada-M of unknown purity have reported negative results, while three studies reported Quellada-M to be mutagenic in bacterial cells. Both technical grade (94–96.5%) and purified (98-99%) Quellada-M 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 Quellada-M are reported to be positive, whereas an in vivo chromosomal aberration study of >99% pure Quellada-M was reported to be negative. Furthermore, mice exposed to Quellada-M 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 Quellada-M.
Reproduction studies performed with Quellada-M 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.
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 Quellada-M, respectively. A study in rats failed to show any gross fetal abnormalities attributable to feeding Quellada-M 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.
Quellada-M 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 Quellada-M® (malathion) Lotion, 0.5% formulation has not been studied, and it is not known whether Quellada-M is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Quellada-M Lotion is administered to (or handled by) a nursing mother.
The safety and effectiveness of Quellada-M Lotion in children less than 6 years of age has not been established via well-controlled trials.
Quellada-M 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 Quellada-M Lotion has the potential to cause contact allergic sensitization.
Consideration should be given, as part of the treatment program, to the high concentration of isopropyl alcohol in the vehicle.
Quellada-M, 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.
Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment.
Two controlled clinical trials evaluated the pediculicidal activity of Quellada-M 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 Quellada-M 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 |
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Quellada-M Lotion | 129/129 | 122/129 | 114/126 |
Quellada-M 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 Quellada-M on hair and scalp is unknown.
Quellada-M® (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
Quellada-M® and TaroPharma® are registered trademarks of Taro Pharmaceuticals U.S.A., Inc. and/or its affiliates.
Revised: November, 2011
70205--1111-1 425
Depending on the reaction of the Quellada-M after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Quellada-M 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 Quellada-M 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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The information was verified by Dr. Rachana Salvi, MD Pharmacology