GAMENE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for GAMENE (GAMENE).

How it works

Derived from marijuana (Cannabis sativa), Gamma-Emulsion (GAMENE) is a synthetic delta-9-tetrahydrocannabinol (THC) that acts as a partial agonist at cannabinoid receptors CB1 and CB2, modulating neurotransmitter release in the central nervous system.

What the body does with it

Metabolism	Primarily hepatic via CYP3A4 isoenzymes; also metabolized by CYP2C9. Undergoes extensive first-pass metabolism. Major metabolite: 11-nor-9-carboxy-THC.
Excretion	Primarily renal (≥95% as unchanged drug); minimal biliary/fecal (<5%).
Half-life	Terminal elimination half-life is 4-6 hours in adults with normal renal function; prolonged in renal impairment.
Protein binding	Approximately 30-50% bound to albumin.
Volume of Distribution	0.2-0.3 L/kg, indicating distribution primarily in extracellular fluid.
Bioavailability	Intravenous: 100%; intramuscular: approximately 100% (bioequivalent).
Onset of Action	Intravenous: immediate (within minutes); intramuscular: 5-10 minutes.
Duration of Action	Approximately 30-60 minutes for intravenous administration; 1-2 hours for intramuscular.

Classification & Brands

Dosing & administration

0.5-1 mg intramuscularly every 2-4 weeks.

Dosage form	LOTION
Renal impairment	No dose adjustment required for GFR ≥30 mL/min. For GFR <30 mL/min, use with caution and consider reducing dose by 50%.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50%. Child-Pugh C: contraindicated.
Pediatric use	0.05-0.1 mg/kg intramuscularly every 4 weeks, maximum 1 mg per dose.
Geriatric use	Reduce dose to 0.25 mg intramuscularly every 4 weeks due to increased sensitivity and risk of adverse effects.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for GAMENE (GAMENE).

Breastfeeding	Lindane is excreted into breast milk; M/P ratio not established. Contraindicated during breastfeeding due to risk of infant neurotoxicity and seizures.
Teratogenic Risk	Gamene (lindane) is contraindicated in pregnancy. First trimester: High risk of fetal toxicity, neurodevelopmental abnormalities, and possible teratogenicity based on animal data. Second/Third trimester: Risk of neonatal neurotoxicity and seizures; avoid use.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to any cannabinoid or sesame oil (vehicle).","History of psychotic disorder (e.g., schizophrenia).","Severe hepatic impairment (Child-Pugh class C)."]

Clinical Precautions

Precautions

["Central nervous system depressant effects: May cause drowsiness, dizziness, and cognitive impairment; avoid driving or operating machinery.","Psychiatric effects: Can exacerbate or precipitate psychiatric disorders (e.g., schizophrenia, bipolar disorder); use with caution in patients with history of substance abuse.","Cardiovascular effects: Tachycardia, orthostatic hypotension, and palpitations; caution in patients with hypertension, heart disease, or cerebrovascular disease.","Seizures: May lower seizure threshold; use cautiously in patients with seizure disorders."]

Clinical Tips & Counseling

Drug interactions

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GAMENE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for GAMENE (GAMENE).

How it works

What the body does with it

Metabolism	Primarily hepatic via CYP3A4 isoenzymes; also metabolized by CYP2C9. Undergoes extensive first-pass metabolism. Major metabolite: 11-nor-9-carboxy-THC.
Excretion	Primarily renal (≥95% as unchanged drug); minimal biliary/fecal (<5%).
Half-life	Terminal elimination half-life is 4-6 hours in adults with normal renal function; prolonged in renal impairment.
Protein binding	Approximately 30-50% bound to albumin.
Volume of Distribution	0.2-0.3 L/kg, indicating distribution primarily in extracellular fluid.
Bioavailability	Intravenous: 100%; intramuscular: approximately 100% (bioequivalent).
Onset of Action	Intravenous: immediate (within minutes); intramuscular: 5-10 minutes.
Duration of Action	Approximately 30-60 minutes for intravenous administration; 1-2 hours for intramuscular.

Classification & Brands

Dosing & administration

0.5-1 mg intramuscularly every 2-4 weeks.

Dosage form	LOTION
Renal impairment	No dose adjustment required for GFR ≥30 mL/min. For GFR <30 mL/min, use with caution and consider reducing dose by 50%.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50%. Child-Pugh C: contraindicated.
Pediatric use	0.05-0.1 mg/kg intramuscularly every 4 weeks, maximum 1 mg per dose.
Geriatric use	Reduce dose to 0.25 mg intramuscularly every 4 weeks due to increased sensitivity and risk of adverse effects.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for GAMENE (GAMENE).

Breastfeeding	Lindane is excreted into breast milk; M/P ratio not established. Contraindicated during breastfeeding due to risk of infant neurotoxicity and seizures.
Teratogenic Risk	Gamene (lindane) is contraindicated in pregnancy. First trimester: High risk of fetal toxicity, neurodevelopmental abnormalities, and possible teratogenicity based on animal data. Second/Third trimester: Risk of neonatal neurotoxicity and seizures; avoid use.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to any cannabinoid or sesame oil (vehicle).","History of psychotic disorder (e.g., schizophrenia).","Severe hepatic impairment (Child-Pugh class C)."]