DRUGS & SUPPLEMENTS
INDICATIONS AND USAGE
Somergan Lotion is indicated for the treatment of scabies (infestations of Sarcoptes scabei ) only in patients who:
Somergan Lotion should be used in the context of an overall scabies management program that includes:
Caregivers applying this product to patients should wear gloves less permeable to Somergan, such as nitrile, latex with neoprene, or sheer vinyl, and thoroughly clean hands after application. Natural latex gloves should be avoided because they are more permeable to Somergan.
Somergan Lotion does not prevent infestation or reinfestation and should not be used to ward off a possible infestation.
Somergan Lotion is contraindicated for premature infants because their skin may be more permeable than that of full term infants and their liver enzymes may not be sufficiently developed to metabolize Somergan.
Somergan Lotion is also contraindicated for patients with crusted (Norwegian) scabies and other skin conditions (e.g., atopic dermatitis, psoriasis) that may increase systemic absorption of the drug.
Somergan Lotion is contraindicated for patients with known uncontrolled seizure disorders and for individuals with a known sensitivity to the product or any of its components.
Seizures and deaths have been reported following Somergan Lotion's use with repeat or prolonged application, but also in rare cases following a single application reportedly used according to directions. It is not known how soon after application of a single dose of Somergan Lotion that a second dose of Somergan Lotion can be safely applied.
There have been cases of adverse events reported for Somergan Lotion and Somergan Shampoo in which a serious outcome (hospitalization, disability or death) has occurred.4 In approximately 20% of the total reported cases, Somergan Lotion and Shampoo were reported to have been used according to the labeled directions. Of these cases, thirteen deaths were reported, many cases which were remote from the time of actual Somergan use. Somergan toxicity, verified by autopsy was the cause of one infant's death, was the cause of death reported for an adult who ingested it orally in a successful suicide. The direct causes of death for the other cases were attributed to reasons other than Somergan. Most of these adverse events occurred with Somergan Lotion.
Infants, children, the elderly, and individuals with other skin conditions and those who weigh < 110 lbs (50 kg) may be at greater risk of serious neurotoxicity. Animal studies have shown increased susceptibility to neurologic adverse events in younger animals. Children have a larger body surface area to volume ratio that may result in a proportionately larger systemic exposure.
Careful consideration should be given before prescribing Somergan Lotion to patients with conditions that may increase the risk of seizure, such as HIV infection, history of head trauma or a prior seizure, CNS tumor, the presence of severe hepatic cirrhosis, excessive use of alcohol, abrupt withdrawal from alcohol or sedatives, as well as concomitant use of medications known to lower seizure threshold.
Patients should be instructed on proper use of Somergan Lotion, especially the amount to apply, how long to leave the lotion on, and the need to avoid retreatment. Patients should be informed that itching may occur, and even worsen, after the successful killing of scabies. Repeat treatment is usually not necessary.
A Somergan Lotion Medication Guide must be given to the patient each time Somergan Lotion is dispensed, as required by law.
Care should be taken to avoid contact with the eyes. If such contact occurs, eyes should be immediately flushed with water. If irritation or sensitization occurs, the patient should be advised to consult a physician.
Information for Patients
Oils may enhance absorption of Somergan, therefore, patients or caregivers applying Somergan Lotion should be warned about simultaneous use of creams, ointments, or oils. In addition, there are many drugs that may lower the seizure threshold, and Somergan Lotion should be prescribed with caution in patients taking these medications. Drugs that may lower the seizure threshold include, but are not limited to the following:
Carcinogenesis, Mutagenesis, and Fertility
Although no studies have been conducted with Somergan Lotion, numerous long-term feeding studies have been conducted in mice and rats to evaluate the carcinogenic potential of the technical grade of hexachlorocyclohexane as well as the alpha, beta, gamma and delta isomers. Both oral and topical applications have been evaluated. Increased incidences of neoplasms were not clearly related to administration of Somergan. The results of mutagenicity tests in bacteria do not indicate that Somergan is mutagenic. Somergan did not cause sister chromatid exchange in an in vivo assay. The number of spermatids in the testes of rats 2 weeks after oral administration of a single dose of 30 mg/kg body weight (12 times the estimated human exposure for scabies on a body surface area comparison and assuming 50% rat oral bioavailability and 10% human bioavailability) was significantly reduced compared to the control rats.
Pregnancy Category C
All pregnancies have a risk of birth defect, loss, or other adverse event regardless of drug exposure. Predictions of fetal risk from drug exposure rely heavily on animal data. However, animal studies may fail to predict effects in humans or may overstate such risks. Even if human data are available, the data may not be sufficient to determine whether there is an increased risk to the fetus, and individual reports of adverse outcomes in pregnancy in association with a drug may not reflect a causal relationship.
Somergan Lotion should be given to pregnant women only if clearly needed. There are no adequate and well-controlled studies of Somergan Lotion in pregnant women. There are no known maternal or fetal health risks if the scabies is not treated. Somergan is lipophilic and may accumulate in the placenta. There has been a single case report of a stillborn infant following multiple maternal exposures to Somergan during pregnancy. The relationship of the maternal exposures to the fetal outcome is unknown.
Animal data suggest that Somergan exposure of the fetus may increase the likelihood of neurologic developmental abnormalities, based on findings at systemic exposures close to that expected in humans when Somergan Lotion is used to treat scabies. The immature central nervous system (as in the fetus) may have increased susceptibility to the effects of the drug.
When rats received Somergan in the diet from day 6 of gestation through day 10 of lactation, reduced pup survival, decreased pup weight and decreased weight gains during lactation, increased motor activity and decreased motor activity habituation were seen in pups at 5.6 mg/kg (2 times the estimated human exposure) but not at 1.2 mg/kg. An increased number of stillborn pups was seen at 8 mg/kg, and increased pup mortality was seen at 5.6 mg/kg. No gross abnormalities were seen in this study or in a study in which rabbits received up to 20 mg/kg Somergan by gavage on gestation day 6–18 (up to 10 times the human exposure on a body surface area comparison and assuming 50% rabbit oral bioavailability and 10% human bioavailability).
Somergan is lipophilic and is present in human breast milk, but exact quantities are not known. There may be a risk of toxicity if Somergan is ingested from breast milk, or from skin absorption from mother to baby in the course of breast-feeding when Somergan Lotion is applied topically to the chest area. Nursing mothers who require treatment with Somergan Lotion should be advised of the potential risks and be counseled to avoid large areas of skin-to-skin contact with the infant while Somergan Lotion is applied, as well as to interrupt breast-feeding, with expression and discarding of milk, for at least 24 hours following use.
Animal data demonstrated increased risk of adverse events in the young across species. Pediatric patients have a higher surface to volume ratio and may be at risk of greater systemic exposure when Somergan Lotion is applied to the body. Infants and children may be at an even higher risk due to immaturity of organ systems such as skin and liver. Somergan Lotion should be used with extreme caution in patients who weigh less than approximately 110 lbs and especially in infants. Somergan Lotion is indicated only for the treatment of scabies; patients with lice should use Somergan Shampoo according to the labeled instructions.
There have been no studies of Somergan Lotion in the elderly. There are four postmarketing reports of deaths in elderly patients who were treated for scabies with Somergan Lotion. Two patients died within 24 hours of Somergan Lotion application, and the third patient died 41 days after application of Somergan Lotion, having suffered a seizure on the day of death. A fourth patient died of an unreported cause of death on the same day that Somergan Lotion treatment for scabies was administered.
Somergan Lotion has been reported to cause central nervous system stimulation ranging from dizziness to seizures. Although seizures were almost always associated with ingestion or misuse of the product, seizures and deaths have been reported when Somergan Lotion was used according to directions. Irritant dermatitis from contact with this product has also been reported.
The following adverse reactions reflect additional postmarketing experience of Somergan Lotion. These events include alopecia, dermatitis, headache, pain, paresthesia, pruritus and urticaria. The relationship of some of these events to Somergan therapy is unknown.
Contact the closest Poison Control Center in the event of suspected overdosage with Somergan Lotion.
If accidental ingestion occurs, prompt gastric lavage should be instituted. However, since oils enhance absorption, saline cathartics for intestinal evacuation should be given rather than oil laxatives. If central nervous system (CNS) manifestations occur, they may be antagonized by the administration of pentobarbital, phenobarbital, or diazepam.
DOSAGE AND ADMINISTRATION
Apply a thin layer of Somergan Lotion over all skin from the neck down. One ounce is sufficient for an average adult. Do not prescribe more than 2 ounces for larger adults. Apply only once. Wash off in 8 to 12 hours. Do not retreat.
Patients should be provided specific information on use of product. Patients should be instructed on proper use of Somergan Lotion, especially the amount to apply, how long to leave on and the need to avoid retreatment. Patients should be informed that itching occurs after the successful killing of scabies (mites) and continued itching is not necessarily an indication for retreatment with Somergan Lotion.
A Somergan Lotion Medication Guide must be given to the patient each time Somergan Lotion is dispensed, as required by law. The Somergan Lotion Medication Guide is an important part of the risk management program for the patient.
Somergan Lotion, USP 1% is supplied in patient-size 2 fl oz (60 mL) bottles.
SHAKE WELL BEFORE USING
Store at 20° to 25°C (68° to 77°F).
Product No.: 8833
Manufactured For: Wockhardt USA, LLC., Parsippany, NJ 07054
Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
PHARMACIST-PATIENT MEDICATION GUIDE PROVIDED BELOW
Somergan (LIHN-dane) Lotion, USP 1%
You must read and follow all instructions before using Somergan Lotion. Read the information you get every time you or a family member get Somergan Lotion. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about Somergan Lotion, ask your doctor or pharmacist.
What is the most important information I should know about Somergan Lotion?
Somergan Lotion is a poison if you do not use it the right way. Somergan Lotion goes through your skin and may affect your brain and nerves. Somergan Lotion can cause seizures, also called convulsions, "fits" or epilepsy.
If you or a family member has a seizure while using Somergan Lotion, get emergency help right away.
What is Somergan Lotion?
Somergan Lotion is a medicine that is used to treat scabies. It kills scabies and their eggs. Scabies are very small bugs (mites) that crawl under your skin, lay eggs, and cause severe itching. Somergan Lotion goes through your skin and kills the scabies and their eggs. Somergan Lotion is used only after safer medicines have not made your scabies go away. The only time Somergan Lotion is used first is when someone cannot use safer medicines, which may include permethrin and crotamiton.
Somergan Lotion is mainly for adults and children who weigh at least 110 pounds. If you weigh less than 110 pounds, use Somergan Lotion only if your doctor thinks it is really needed. People who weigh less than 110 pounds and the elderly have higher chances for side effects because more Somergan may go through their skin.
Who should not use Somergan Lotion?
Do not use Somergan Lotion:
Tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may increase your chances of having a seizure if you take them while using Somergan Lotion. Especially, tell your doctor if you take medicines called sedatives (drugs to help you sleep).
How do I use Somergan Lotion?
Before you put it on:
When you put it on:
When you are supposed to wash it off:
After you wash off the Somergan Lotion:
You may still itch after you use Somergan Lotion. This does not mean you need more Somergan Lotion. Even after all the scabie bugs (mites) are dead, they can still make your skin itch for a few weeks. Somergan Lotion sometimes makes this itch even worse. Talk to your doctor about things you can do to soothe the itch.
What should I avoid while using Somergan Lotion?
What are the possible side effects of Somergan Lotion?
Somergan Lotion may cause serious side effects such as seizures (convulsions, fits) or death. Somergan Lotion can also make you feel sleepy, dizzy, or can cause body shaking that you cannot control.
The most common side effects of Somergan Lotion are:
These are not all of the possible side effects of Somergan Lotion. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General Information about Somergan Lotion:
Medicines are sometimes prescribed for purposes other than those listed in Medication Guides. Do not use Somergan Lotion for any condition for which it was not prescribed. Do not give Somergan Lotion to other people, even if they have the same symptoms that you have. It may harm them. Keep Somergan Lotion and all medicines out of the reach of children.
This Medication Guide summarizes the most important information about Somergan Lotion. If you want more information, talk with your doctor. You can ask your doctor or pharmacist for information about Somergan Lotion that is written for health professionals.
What are the ingredients in Somergan Lotion?
Active Ingredient: Somergan.
Inactive Ingredients: 2-amino-2-methyl-1-propanol, carrageenan, cetyl alcohol, cocoa butter, glyceryl monostearate, methylparaben, propylene glycol, propylparaben, purified water, stearic acid and trolamine.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
This medication is available only by a prescription from your doctor.
Product No.: 8833
Wockhardt USA, LLC., Parsippany, NJ 07054
Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
Somergan 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.
Somergan 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.
Somergan 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.
Somergan 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.
Somergan 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.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Somergan?
Depending on the reaction of the Somergan after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Somergan 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 Somergan 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.
ReviewsDrugs.com conducted a study on Somergan, 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 Somergan 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.
The information was verified by Dr. Arunabha Ray, MD Pharmacology