Gamma-Scab Lotion

Lidocaine Hydrochloride:

• Pharmacological action
• Pharmacokinetics
• Why is Gamma-Scab Lotion prescribed?
• Dosage and administration
• Gamma-Scab Lotion (Lidocaine Hydrochloride) side effects, adverse reactions
• Gamma-Scab Lotion contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Gamma-Scab Lotion drug interactions
• Gamma-Scab Lotion in case of emergency / overdose
• Gamma-Scab Lotion (Lidocaine Hydrochloride) reviews

Pharmacological action

Gamma-Scab Lotion is an antiarrhythmic agent of class IB, local anesthetic, a derivative of acetanilide. This medication has membrane stabilizing activity. Gamma-Scab Lotion (Lidocaine Hydrochloride) causes a blockade of sodium channels of excitable membranes of neurons and the membrane of cardiomyocytes.

This drug reduces the duration of the action potential and effective refractory period in Purkinje fibers, inhibits their automaticity. In this case, Gamma-Scab Lotion (Lidocaine Hydrochloride) inhibits electrical activity in depolarized, arrhythmogenic sites, but minimally affects the electrical activity of normal tissues. When used in the medium therapeutic doses virtually no effect on myocardial contractility and slows AV-conduction. When applied as an antiarrhythmic agent in IV injection it begin to act in 45-90 seconds, the duration of action is 10-20 minutes; for IM administration the onset of action is in 5-15 minutes, the duration - 60-90 minutes.

Gamma-Scab Lotion (Lidocaine Hydrochloride) causes all kinds of local anesthesia: a terminal, infiltration and wires.

Pharmacokinetics

After IM administration absorption of Gamma-Scab Lotion (Lidocaine Hydrochloride) is almost complete. The distribution is rapid, Vd is about 1 L/kg (in patients with heart failure it is below). The protein binding depends on the concentration of the active substance in the plasma and is 60-80%. Gamma-Scab Lotion (Lidocaine Hydrochloride) metabolized mainly in the liver with the formation of active metabolites, that may contribute to the manifestation of the therapeutic and toxic effects, especially after the infusion for 24 hours or more.

T_1/2 tends to be two phases with the phase distribution of 9.7 min. In general T_1/2 depends on the dose is 1-2 hours and can grow up to 3 hours or more during prolonged intravenous infusion (over 24 h). Gamma-Scab Lotion (Lidocaine Hydrochloride) excreted by the kidneys as metabolites, 10% unchanged.

Why is Gamma-Scab Lotion prescribed?

In cardiological practice: treatment and prevention of ventricular arrhythmias (extrasystoles, tachycardia, atrial flutter, atrial fibrillation), including in acute myocardial infarction, implantation of artificial pacemaker in the glycoside intoxication, narcosis.

Anaesthesia: terminal, infiltration, conduction, spinal (epidural) anesthesia in surgery, obstetrics and gynecology, urology, ophthalmology, dentistry, otolaryngology, blockade of peripheral nerves and ganglion.

Dosage and administration

As an anti-arrhythmic medicine for adult with the introduction of a loading dose by IV - 1-2 mg / kg over 3-4 minutes; the average single dose is 80 mg. Then immediately transferred to drip infusion at a rate of 20-55 mg / kg / min. Drip infusion can be carried out within 24-36 hours. If necessary, against the background of drop infusions can repeat IV jet injection of Gamma-Scab Lotion 40 mg after 10 minutes after the first loading dose.

IM is introduced to 2-4 mg / kg, if necessary, repeated administration is possible through 60-90 minutes.

For children with IV injection loading dose - 1 mg / kg, if necessary, it may be repeated administration in 5 min.

For continuous intravenous infusion (usually following the introduction of a loading dose) - 20-30 mg / kg / min.

For use in surgical and obstetric practice, dentistry, ENT practice, dosing regimen set individually, depending on the evidence, the clinical situation and used the dosage form.

Maximum dose: for adults for IV injections the loading dose is 100 mg, in a subsequent drop infusion it is 2 mg / min; when IM administration - 300 mg (about 4.5 mg / kg) for 1 h.

For children in case of reintroduction the loading dose every 5 minutes, the total dose is 3 mg / kg; by continuous intravenous infusion (usually following the introduction of a loading dose) - 50 mg / kg / min.

Gamma-Scab Lotion (Lidocaine Hydrochloride) side effects, adverse reactions

CNS and peripheral nervous system: dizziness, headache, weakness, motor restlessness, nystagmus, loss of consciousness, drowsiness, visual and auditory disturbances, tremor, trismus, seizures (risk of their development against the backdrop of increasing hypercapnia and acidosis), a syndrome of "cauda equina" (paralysis of the legs, paresthesia), paralysis of respiratory muscles, respiratory arrest, a block of motor and sensitive, respiratory paralysis (usually develops in the subarachnoid anesthesia), numb tongue (when used in dentistry).

Cardiovascular system: increased or decreased blood pressure, tachycardia if used with a vasoconstrictor, peripheral vasodilatation, collapse, chest pain.

Digestive system: nausea, vomiting, involuntary defecation.

Allergic reactions: skin rash, hives (on skin and mucous membranes), itching, angioedema, anaphylactic shock.

Local reactions: during spinal anesthesia - a pain in the back, with an epidural anesthesia - a random hit in the subarachnoid space, when applied topically in urology - urethritis.

Other: incontinent, methemoglobinemia, persistent anesthesia, decreased libido and / or potency, respiratory depression, until the stop, hypothermia; during anesthesia in dentistry: numbness and paresthesia of the lips and tongue, the lengthening of anesthesia.

Gamma-Scab Lotion contraindications

Severe bleeding, shock, hypotension, infection of the proposed injection site, marked bradycardia, cardiogenic shock, severe forms of chronic heart failure, SSS in elderly patients, AV-block II and III degree (except in cases when the probe was introduced to stimulate the ventricles), severe liver function abnormalities.

For subarachnoid anesthesia - complete heart block, bleeding, hypotension, shock, infection of the venue lumbar puncture, septicemia.

Increased sensitivity to Gamma-Scab Lotion (Lidocaine Hydrochloride) and other amide type local anesthetics.

Using during pregnancy and breastfeeding

During pregnancy and lactation be used only for health reasons. Gamma-Scab Lotion is excreted in breast milk.

In obstetric practice used with caution in paracervical for violations of fetal development, placental insufficiency, prematurity, postmaturity, gestosis.

Category effects on the fetus by FDA - B.

Special instructions

Use with caution in liver disease and kidney failure, hypovolemia, severe heart failure, in violation of the contractility of genetic susceptibility to malignant hyperthermia. In children, debilitated patients, elderly patients are required in dosage adjustment in accordance with the age and physical status. When injected into vascularized tissue it is recommended an aspiration test.

Gamma-Scab Lotion drug interactions

Beta-blockers increase the risk of bradycardia and hypotension. Norepinephrine and beta-blockers by reducing hepatic blood flow decrease (increased toxicity), isadrine and glucagon - increase the clearance of Gamma-Scab Lotion (Lidocaine Hydrochloride). Cimetidine increases the plasma concentration of Gamma-Scab Lotion (Lidocaine Hydrochloride) (displaces from its association with proteins and slows inactivation in the liver). Barbiturates causing induction of microsomal enzymes stimulate the degradation of Gamma-Scab Lotion (Lidocaine Hydrochloride) and reduce its activity. Anticonvulsants (hydantoin derivatives) accelerate the biotransformation in the liver (decreased concentration in the blood), for IV injections it may increases cardiodepressive action of Gamma-Scab Lotion (Lidocaine Hydrochloride). Antiarrhythmics (amiodarone, verapamil, quinidine, aymalin) potentiate cardiac depression. Combination with novocainamide may cause CNS excitement and hallucinations. Gamma-Scab Lotion (Lidocaine Hydrochloride) strengthens the inhibitory effect of anesthesia (hexobarbital, thiopental sodium), hypnotics and sedatives on the respiratory center, weakens the cardiac effects of digitoxin, enhances muscle relaxation caused by drugs curare like (possible paralysis of respiratory muscles). MAO inhibitors prolong local anesthesia.

Gamma-Scab Lotion in case of emergency / overdose

Symptoms: psychomotor agitation, dizziness, weakness, decreased blood pressure, tremors, tonic-clonic convulsions, coma, collapse, possible AV blockade, CNS depression, respiratory arrest.

Treatment: discontinuation, pulmonary ventilation, oxygen therapy, anticonvulsants, vasoconstrictors (norepinephrine, mezaton), when bradycardia - anticholinergics (atropine). It is possible to carry out intubation, mechanical ventilation, resuscitation. Dialysis is ineffective.

Lindane:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• References
• Medication guide
• Gamma-Scab Lotion (Lindane) reviews

INDICATIONS AND USAGE

Gamma-Scab Lotion (Lindane) Lotion is indicated for the treatment of scabies (infestations of Sarcoptes scabei ) only in patients who:

• cannot tolerate other approved therapies, or
• have failed treatment with other approved therapies.

Gamma-Scab Lotion (Lindane) Lotion should be used in the context of an overall scabies management program that includes:

• Microscopic evaluation of skin scrapings to confirm the diagnosis.
• Evaluation and treatment of sexual contacts simultaneously. Sexual contacts should be prescribed Gamma-Scab Lotion (Lindane) Lotion only if they either have failed to respond to adequate doses of other approved therapies or are intolerant of other approved therapies.
• Washing of all recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels in very hot water or dry-cleaned.

Caregivers applying this product to patients should wear gloves less permeable to Gamma-Scab Lotion (Lindane), 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 Gamma-Scab Lotion (Lindane).

Gamma-Scab Lotion (Lindane) Lotion does not prevent infestation or reinfestation and should not be used to ward off a possible infestation.

CONTRAINDICATIONS

Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane).

Gamma-Scab Lotion (Lindane) 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.

Gamma-Scab Lotion (Lindane) 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.

WARNINGS

Seizures and deaths have been reported following Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) Lotion that a second dose of Gamma-Scab Lotion (Lindane) Lotion can be safely applied.

There have been cases of adverse events reported for Gamma-Scab Lotion (Lindane) Lotion and Gamma-Scab Lotion (Lindane) Shampoo in which a serious outcome (hospitalization, disability or death) has occurred.⁴ In approximately 20% of the total reported cases, Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) use. Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane). Most of these adverse events occurred with Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) Lotion Medication Guide must be given to the patient each time Gamma-Scab Lotion (Lindane) Lotion is dispensed, as required by law.

PRECAUTIONS

General

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

• This product can be poisonous if misused.
• Other important information is found in the Medication Guide, which by law, must be dispensed with Gamma-Scab Lotion (Lindane) Lotion.
• If someone other than the patient will be applying Gamma-Scab Lotion (Lindane) Lotion to the patient, they should wear less permeable gloves such as nitrile, latex with neoprene, or sheer vinyl, and thoroughly clean their hands after application. Natural latex gloves should be avoided because they are more permeable to Gamma-Scab Lotion (Lindane).
• If the person applying Gamma-Scab Lotion (Lindane) Lotion could be pregnant, contact with Gamma-Scab Lotion (Lindane) Lotion should be avoided as much as possible.
• If the patient could be pregnant, other treatments may be preferable.
• Gamma-Scab Lotion (Lindane) Lotion should be used for scabies only.
• The skin should be clean and without any other lotion, cream, or oil on it. Oils can make the Gamma-Scab Lotion (Lindane) Lotion go through the skin faster and possibly increase the risk of neurotoxicity (e.g., seizures).
• Wait at least 1 hour after bathing or showering before putting Gamma-Scab Lotion (Lindane) Lotion on the skin. Wet or warm skin can make the Gamma-Scab Lotion (Lindane) Lotion go through skin faster.
• Information for Use:
  • Shake Gamma-Scab Lotion (Lindane) Lotion well.
  • Put Gamma-Scab Lotion (Lindane) Lotion under fingernails after trimming the fingernails short, because scabies are very likely to remain there. A toothbrush can be used to apply the Gamma-Scab Lotion (Lindane) Lotion under the fingernails. Immediately after use, the toothbrush should be wrapped in paper and thrown away. Use of the same brush in the mouth could lead to poisoning.
  • Use only a single application, applied as a very thin layer over all skin from the neck down.
  • Close the bottle with the leftover Gamma-Scab Lotion (Lindane) Lotion and immediately throw it away in a trash can out of the reach of children.
  • Do not use any covering over the applied Gamma-Scab Lotion (Lindane) Lotion that does not breathe, like diapers with plastic lining, plastic clothes, tight clothes, or blankets.
  • Wash the Gamma-Scab Lotion (Lindane) Lotion completely off after 8 to 12 hours. Never leave Gamma-Scab Lotion (Lindane) Lotion on the skin for more than 12 hours. Warm, but not hot water can be used. Gamma-Scab Lotion (Lindane) Lotion will not kill any more scabies after 8 to 12 hours, but may cause serious health problems.
  • Keep Gamma-Scab Lotion (Lindane) Lotion away from mouth and eyes. If contact with eyes occurs, immediately flush eyes with water. Do not use if you have open wounds, cuts or sores that are present, unless specifically directed by the prescribing physician.
  • All recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned.
  • The patient may still itch after using Gamma-Scab Lotion (Lindane) Lotion. This does not mean the medicine did not work. Even after all the scabies (mites) are dead, they can still make the skin itch for a few weeks. Gamma-Scab Lotion (Lindane) Lotion sometimes makes this itch even worse. Other treatments can be used to soothe the itch. Do not use more Gamma-Scab Lotion (Lindane) Lotion.
  • The patient should contact the physician with any questions or concerns about his or her condition or use of the Gamma-Scab Lotion (Lindane) Lotion.

Drug Interactions

Oils may enhance absorption of Gamma-Scab Lotion, therefore, patients or caregivers applying Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) 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:

• Antipsychotics
• Antidepressants
• Theophylline
• Cyclosporine, mycophenolate mofetil, tacrolimus capsules
• Penicillins, imipenem, quinolone antibiotics
• Chloroquine sulfate, pyrimethamine
• Isoniazid
• Meperidine
• Radiographic contrast agents
• Centrally active anticholinesterases
• Methocarbamol

Carcinogenesis, Mutagenesis, and Fertility

Although no studies have been conducted with Gamma-Scab Lotion (Lindane) 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 (lindane) and delta isomers. Both oral and topical applications have been evaluated. Increased incidences of neoplasms were not clearly related to administration of Gamma-Scab Lotion (Lindane). The results of mutagenicity tests in bacteria do not indicate that Gamma-Scab Lotion (Lindane) is mutagenic. Gamma-Scab Lotion (Lindane) 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

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.

Gamma-Scab Lotion Lotion should be given to pregnant women only if clearly needed. There are no adequate and well-controlled studies of Gamma-Scab Lotion (Lindane) Lotion in pregnant women. There are no known maternal or fetal health risks if the scabies is not treated. Gamma-Scab Lotion (Lindane) is lipophilic and may accumulate in the placenta. There has been a single case report of a stillborn infant following multiple maternal exposures to Gamma-Scab Lotion (Lindane) during pregnancy. The relationship of the maternal exposures to the fetal outcome is unknown.

Animal data suggest that Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) 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.

Data

When rats received Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) 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).

Nursing Mothers

Gamma-Scab Lotion is lipophilic and is present in human breast milk, but exact quantities are not known. There may be a risk of toxicity if Gamma-Scab Lotion (Lindane) is ingested from breast milk, or from skin absorption from mother to baby in the course of breast-feeding when Gamma-Scab Lotion (Lindane) Lotion is applied topically to the chest area. Nursing mothers who require treatment with Gamma-Scab Lotion (Lindane) Lotion should be advised of the potential risks and be counseled to avoid large areas of skin-to-skin contact with the infant while Gamma-Scab Lotion (Lindane) Lotion is applied, as well as to interrupt breast-feeding, with expression and discarding of milk, for at least 24 hours following use.

Pediatric 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 Gamma-Scab Lotion (Lindane) 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. Gamma-Scab Lotion (Lindane) Lotion should be used with extreme caution in patients who weigh less than approximately 110 lbs (50 kg) and especially in infants. Gamma-Scab Lotion (Lindane) Lotion is indicated only for the treatment of scabies; patients with lice should use Gamma-Scab Lotion (Lindane) Shampoo according to the labeled instructions.

Geriatric Use

There have been no studies of Gamma-Scab Lotion (Lindane) Lotion in the elderly. There are four postmarketing reports of deaths in elderly patients who were treated for scabies with Gamma-Scab Lotion (Lindane) Lotion. Two patients died within 24 hours of Gamma-Scab Lotion (Lindane) Lotion application, and the third patient died 41 days after application of Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) Lotion treatment for scabies was administered.

ADVERSE REACTIONS

Gamma-Scab Lotion 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 (to include repeat treatment), seizures and deaths have been reported when Gamma-Scab Lotion (Lindane) Lotion was used according to directions. Irritant dermatitis from contact with this product has also been reported.

Postmarketing Experience

The following adverse reactions reflect additional postmarketing experience of Gamma-Scab Lotion (Lindane) Lotion. These events include alopecia, dermatitis, headache, pain, paresthesia, pruritus and urticaria. The relationship of some of these events to Gamma-Scab Lotion (Lindane) therapy is unknown.

OVERDOSAGE

Contact the closest Poison Control Center in the event of suspected overdosage with Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) Lotion.

A Gamma-Scab Lotion (Lindane) Lotion Medication Guide must be given to the patient each time Gamma-Scab Lotion (Lindane) Lotion is dispensed, as required by law. The Gamma-Scab Lotion (Lindane) Lotion Medication Guide is an important part of the risk management program for the patient.

HOW SUPPLIED

Gamma-Scab Lotion (Lindane) 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).

REFERENCES

• Feldmann, R.J. and Maibach, H.I., Toxicol. Applied. Pharmacol., 28:126, 1974.
• Dale, W.E., Curly, A. and Cueto, C. Life Sci 5:47, 1966.
• Ginsburg, C.M., et al., J. Pediatr. 91:6, 998–1000, 1977.
• FDA AERS database search, January 2003

Rx Only

Product No.: 8833

Manufactured For: Wockhardt USA, LLC., Parsippany, NJ 07054

Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

A50-8833-60

REV. 09-09

PHARMACIST-PATIENT MEDICATION GUIDE PROVIDED BELOW

MEDICATION GUIDE

Gamma-Scab Lotion (Lindane) (LIHN-dane) Lotion, USP 1%

You must read and follow all instructions before using Gamma-Scab Lotion (Lindane) Lotion. Read the information you get every time you or a family member get Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) Lotion, ask your doctor or pharmacist.

What is the most important information I should know about Gamma-Scab Lotion (Lindane) Lotion?

Gamma-Scab Lotion (Lindane) Lotion is a poison if you do not use it the right way. Gamma-Scab Lotion (Lindane) Lotion goes through your skin and may affect your brain and nerves. Gamma-Scab Lotion (Lindane) Lotion can cause seizures, also called convulsions, "fits" or epilepsy.

• Seizures and death can happen in people who use Gamma-Scab Lotion (Lindane) Lotion too much or too often.
• Seizures can happen in some people even if they use Gamma-Scab Lotion (Lindane) Lotion exactly as directed.

If you or a family member has a seizure while using Gamma-Scab Lotion (Lindane) Lotion, get emergency help right away.

• Do not use Gamma-Scab Lotion (Lindane) Lotion unless:
  • You have scabies and were treated with another medicine that did not work for you, or
  • You cannot use other safer medicines to treat your scabies.
• Do not use Gamma-Scab Lotion (Lindane) Lotion more than 1 time to treat an attack of scabies. Do not use Gamma-Scab Lotion (Lindane) Lotion to treat a second attack of scabies that comes soon after the first episode. Using it more than 1 time can cause seizures and death. No one knows a safe time to reuse Gamma-Scab Lotion (Lindane) Lotion. Even if you still itch after using Gamma-Scab Lotion (Lindane) Lotion, do not use more or use it again. Scabies (mites) can make your skin itch for a few weeks even after all of the bugs (mites) are dead.
• Do not use more Gamma-Scab Lotion (Lindane) Lotion than your doctor tells you.
• Do not keep Gamma-Scab Lotion (Lindane) Lotion on your skin for more than 8 to 12 hours.
• Do not put Gamma-Scab Lotion (Lindane) Lotion in your mouth because it is a poison if taken by mouth. If you get Gamma-Scab Lotion (Lindane) Lotion in your mouth or swallow Gamma-Scab Lotion (Lindane) Lotion, call your area Poison Control Center right away and get emergency help.

What is Gamma-Scab Lotion (Lindane) Lotion?

Gamma-Scab Lotion (Lindane) 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. Gamma-Scab Lotion (Lindane) Lotion goes through your skin and kills the scabies and their eggs. Gamma-Scab Lotion (Lindane) Lotion is used only after safer medicines have not made your scabies go away. The only time Gamma-Scab Lotion (Lindane) Lotion is used first is when someone cannot use safer medicines, which may include permethrin and crotamiton.

Gamma-Scab Lotion (Lindane) Lotion is mainly for adults and children who weigh at least 110 pounds. If you weigh less than 110 pounds, use Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) may go through their skin.

Who should not use Gamma-Scab Lotion (Lindane) Lotion?

Do not use Gamma-Scab Lotion (Lindane) Lotion:

• if you do not have scabies. Gamma-Scab Lotion (Lindane) Lotion does not stop you from getting scabies. Gamma-Scab Lotion (Lindane) Lotion only kills the scabies you already have.
• if you have or have ever had seizures, also called convulsions, "fits" or epilepsy, especially if they have been hard to control.
• if you used Gamma-Scab Lotion (Lindane) Lotion in the past few months. You should see your doctor if you think you need another treatment.
• unless it is the only medicine you can use for scabies.
• if you had a bad reaction to Gamma-Scab Lotion (Lindane) Lotion before. Do not use Gamma-Scab Lotion (Lindane) Lotion again.
• if you have open sores or crusted (scabby) sores on your skin, or lots of broken skin.
• if you have head or body lice. These need a different medicine that you use in a different way.
• if you are allergic to Gamma-Scab Lotion (Lindane) Lotion or any of its ingredients. The active ingredient is Gamma-Scab Lotion (Lindane). See the end of this Medication Guide for a list of all the ingredients in Gamma-Scab Lotion (Lindane) Lotion.
• if you need to treat a premature or young baby. More Gamma-Scab Lotion (Lindane) can go through the skin of babies and go to their brains where it can harm them.
• while you are breast-feeding. Gamma-Scab Lotion (Lindane) Lotion can get in your milk and be fed to your baby. Gamma-Scab Lotion (Lindane) Lotion on your skin can also go to your baby. Your baby may get sick. Ask your doctor for a safer medicine. If you use Gamma-Scab Lotion (Lindane) Lotion, pump your breast milk and throw away the milk for at least 24 hours after using the medicine. During this time, feed your baby formula or breast milk you stored from before you used Gamma-Scab Lotion (Lindane) Lotion.

Tell your doctor if you:

• used Gamma-Scab Lotion (Lindane) Lotion in the past few months.
• ever had a seizure or problem that could increase your chances of getting a seizure (like a head injury, tumor in your brain or spinal cord, cirrhosis of the liver, or heavy alcohol drinking.)
• have HIV or AIDS. Gamma-Scab Lotion (Lindane) Lotion may cause seizures even if you never had them before.
• are pregnant. Gamma-Scab Lotion (Lindane) Lotion can reach your baby and may harm it. Ask your doctor for a safer medicine. Use Gamma-Scab Lotion (Lindane) Lotion only if needed.
• have a sexual partner. Your partner should get checked and treated for scabies so they don't give them back to you. Don't share your Gamma-Scab Lotion (Lindane) Lotion with your partner.

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 Gamma-Scab Lotion (Lindane) Lotion. Especially, tell your doctor if you take medicines called sedatives (drugs to help you sleep).

How do I use Gamma-Scab Lotion (Lindane) Lotion?

Before you put it on:

• Make sure you know how to use it exactly as your doctor prescribes.
• If you are putting Gamma-Scab Lotion (Lindane) Lotion on another person, wear special gloves made of nitrile, latex with neoprene, or sheer vinyl. Do not use natural latex gloves because more Gamma-Scab Lotion (Lindane) can go through that kind of glove. Wash your hands well when you are done.
• Make sure your skin is clean and does not have any other lotion, cream, or oil on it. Oils can make Gamma-Scab Lotion (Lindane) Lotion go through your skin faster and may increase the risk of seizures.
• Wait for at least 1 hour after bathing or showering before you put Gamma-Scab Lotion (Lindane) Lotion on your skin. Wet or warm skin can make the Gamma-Scab Lotion (Lindane) Lotion go through your skin faster and may increase the risk of seizures.

When you put it on:

• Shake the bottle of Gamma-Scab Lotion (Lindane) Lotion well.
• Put Gamma-Scab Lotion (Lindane) Lotion under your fingernails, because the scabies really like to stay there. Trim your fingernails short. Use a toothbrush to get the Gamma-Scab Lotion (Lindane) Lotion under your fingernails. Wrap this toothbrush in paper and throw this toothbrush away. Do not use it in your mouth.
• Put a very thin layer of the Gamma-Scab Lotion (Lindane) Lotion on your skin from the neck down. You may have some Gamma-Scab Lotion (Lindane) Lotion left in the bottle.
• Do not cover over the Gamma-Scab Lotion (Lindane) Lotion on your skin with anything that does not breathe, like diapers with a plastic lining, plastic clothes, tight clothes, or blankets.
• Close the bottle with the leftover Gamma-Scab Lotion (Lindane) Lotion and throw it away in a trash can out of the reach of children.

When you are supposed to wash it off:

• Wash the Gamma-Scab Lotion (Lindane) Lotion off your skin after 8 to 12 hours. You must wash the Gamma-Scab Lotion (Lindane) Lotion off your body completely. Use warm, but not hot water. Gamma-Scab Lotion (Lindane) Lotion will not kill any more scabies after 8 to 12 hours. After 8 to 12 hours, Gamma-Scab Lotion (Lindane) Lotion can cause serious health problems, such as seizures and death.

After you wash off the Gamma-Scab Lotion (Lindane) Lotion:

• All recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned.
• Do not use Gamma-Scab Lotion (Lindane) Lotion again. If you think you need to use it again, you must check with your doctor to find out when it is most safe.

You may still itch after you use Gamma-Scab Lotion (Lindane) Lotion. This does not mean you need more Gamma-Scab Lotion (Lindane) Lotion. Even after all the scabie bugs (mites) are dead, they can still make your skin itch for a few weeks. Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) Lotion?

• Do not get Gamma-Scab Lotion (Lindane) Lotion in your eyes. If you do, rinse your eyes with water right away. Get medical help if your eyes keep hurting.
• Do not let your skin touch other people's skin while you have Gamma-Scab Lotion (Lindane) Lotion on. Make sure your skin does not touch your baby or small child.
• If you are pregnant, do not use Gamma-Scab Lotion (Lindane) Lotion, or apply Gamma-Scab Lotion (Lindane) Lotion to others unless it is needed and you have talked to your doctor about using it. See the special glove advice below if you have to put Gamma-Scab Lotion (Lindane) Lotion on others.
• Do not use oils on your skin or hair just before or after using Gamma-Scab Lotion (Lindane) Lotion. Oils include skin lotions and moisturizers, and oil-based hair products and conditioners.
• Do not get Gamma-Scab Lotion (Lindane) Lotion on your hands if you are putting it on someone else. Wear special gloves made of nitrile, latex with neoprene, or sheer vinyl. Do not use natural latex gloves. Wash your hands well when you are done.

What are the possible side effects of Gamma-Scab Lotion (Lindane) Lotion?

Gamma-Scab Lotion (Lindane) Lotion may cause serious side effects such as seizures (convulsions, fits) or death Lotion?"). Gamma-Scab Lotion (Lindane) Lotion can also make you feel sleepy, dizzy, or can cause body shaking that you cannot control.

The most common side effects of Gamma-Scab Lotion (Lindane) Lotion are:

• Itching skin
• Burning skin
• Dry skin
• A skin rash

These are not all of the possible side effects of Gamma-Scab Lotion (Lindane) 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 Gamma-Scab Lotion (Lindane) Lotion:

Medicines are sometimes prescribed for purposes other than those listed in Medication Guides. Do not use Gamma-Scab Lotion (Lindane) Lotion for any condition for which it was not prescribed. Do not give Gamma-Scab Lotion (Lindane) Lotion to other people, even if they have the same symptoms that you have. It may harm them. Keep Gamma-Scab Lotion (Lindane) Lotion and all medicines out of the reach of children.

This Medication Guide summarizes the most important information about Gamma-Scab Lotion (Lindane) Lotion. If you want more information, talk with your doctor. You can ask your doctor or pharmacist for information about Gamma-Scab Lotion (Lindane) Lotion that is written for health professionals.

What are the ingredients in Gamma-Scab Lotion (Lindane) Lotion?

Active Ingredient: Gamma-Scab Lotion (Lindane).

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

Manufactured For:

Wockhardt USA, LLC., Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

A50-8833-60

REV. 09-09