COMPOSITION :
GAMITE LOTION
Gamma Benzene
Hexachloride (Lindane) 2% w/v
Cetrimide 0.5% w/v
CLINICAL PHARMACOLOGY :
Lindane (Gamma Benzene Hexachloride) exerts its parasiticidal action by being directly absorbed into the parasites and their ova. It is used for treatment of scabies. The drug is also a very active pediculocide and is effective in the treatment of pediculosis pubis, capitis, and corporis. Cetrimide on account of its antiseptic properties, controls bacterial super infection, thereby supporting the miticidal action of Gamma Benzene Hexachloride.
INDICATIONS :
1. In scabies
2. In pediculosis.
DOSAGE AND ADMINISTRATION :
A) In scabies
Method of application :
- Take soap and warm water bath prior to application. Dry and cool the affected site.
- Apply a thin layer of GAMITE LOTION from neck down and rub thoroughly.
- The lotion should be left for 12 hours (usually overnight) and then removed by thorough washing.
- Care should be taken, so that the lotion dose not come in contact with eyes, and mucous membrane.
- Pruritus is usually relieved within 24 hours and the great majority of patients do not require a second treatment. If necessary, however, second and third applications can be made at weekly intervals.
B) In pediculosis
Method of application :
- Before using GAMITE LOTION in pediculosis, shampoo the hair, rinse and completely dry the hair.
- Apply sufficient quantity of GAMITE LOTION to the dry hair, rub in for 4 minutes, leave in contact for 12 hours (usually overnight), and then wash off.
- Remaining eggs to be removed with nit comb.
- Retreatment usually is not necessary, but presence of living lice in hair 7 days after treatment indicates that retreatment may be necessary.
- All contact treatment: Since chances of ping-pong infection is there in scabies and pediculosis, all family members should be treated together.
CONTRAINDICATIONS :
· Infants (less than 2 years).
· Pregnant women and Nursing mothers.
WARNINGS AND PRECAUTIONS :
GAMITE LOTION penetrates human skin and has the potential for CNS toxicity. GAMITE LOTION should be used according to the directions for use especially on infants, pregnant women and nursing mothers. Animal studies indicate that potential toxic effects of topically applied lindane are greater in the young.
Avoid over- exposure, frequent reapplications. Accidental and intentional ingestion may be fatal. Seizures, also have been reported with Lindane. Children should not be allowed to apply on their own. An adult’s presence and supervision is mandatory. The preparation should be kept away from the reach of young children. Utmost care should be taken to avoid contact with eyes.
ADVERSE REACTIONS :
Lindane has been reported to cause central nervous stimulation ranging from dizziness to convulsions. Cases of convulsions have been reported in connection with lindane lotion therapy. However these incidents were almost always associated with accidental oral ingestion or misuse of the product. In exceedingly rare cases, seizures have been reported when used according to direction. Eczematous eruptions due to irritation from this product have also been reported. Incidence of these adverse reactions is relatively infrequent, occurring in less than 1 in 100,000 patients.
STORAGE INSTRUCTIONS :
Store in a cool, dry place. Keep out of reach of children.