LYNDAVEL Medroxyprogesterone Acetate 150mg / mL Suspension for IM Injection 1mL 25's
RXDRUG-DRP-338
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Medroxyprogesterone Acetate (LYNDAVEL) is indicated for contraception and treatment of menorrhagia, secondary amenorrhea and mild to moderate endometriosis.
Dosage/Direction for Use
Consult a healthcare provider for a medical and gynecological examination before the administration of Medroxyprogesterone Acetate (LYNDAVEL).
For contraception and menorrhagia: A single vial [150 mg of Medroxyprogesterone Acetate (LYNDAVEL) in 1 mL suspension] within the first seven days of cycle or within first four weeks after giving birth (delay until six weeks after giving birth if breastfeeding). The patient can also have it injected any day as long as the patient is not pregnant and be sure to use a back up method such as a condom for the next seven days as a precaution to avoid pregnancy.
For secondary amenorrhea: 5 to 10 mg daily by intramuscular injection for about five to ten days until two days before the anticipated onset of menstruation.
For mild to moderate endometriosis: 50 mg weekly or 100 mg every two weeks by intramuscular injection for at least six months.
As follows are the steps in using Medroxyprogesterone Acetate (LYNDAVEL): 1. Wash hands with soap and water. If injection site is dirty, wash it with soap and water.
2. Gently shake the vial. If vial is cold, warm to skin temperature before giving the injection.
3. Pierce top of vial with sterile needle and fill syringe with proper dose.
4. Insert sterile needle deep into the hip (ventrogluteal muscle), the upper arm, (deltoid muscle), or the buttocks (gluteal muscle, upper outer portion), whichever the woman prefers. Inject the contents of the syringe. Do not massage the injection site. This could cause Medroxyprogesterone Acetate (LYNDAVEL) to be absorbed too fast.
5. Used disposable syringe and needle must be properly disposed by placing in a puncture-proof container.
6. The next injection can be administered two weeks before or four weeks after the scheduled day.
Missed Dose: For effective prevention of pregnancy, the patient must return. to the doctor every three months for the next injection. The next injection can be given two weeks before or 4 weeks after the scheduled day of the injection.
If the patient is less than 4 weeks late for the repeat injection, the doctor may give the next injection. The patient will not need a back-up contraceptive method, such as a condom for the next 7 days.
If the patient is more than 4 weeks late for the repeat injections, the patient can receive the next dose as long as the patient has not had sex since 2 weeks after the scheduled date of the injection or if the patient is reasonably certain that she is not pregnant; and the patient will need a back-up contraceptive method such as condom for the next 7 days after the injection.
If the patient keeps forgetting to return for the scheduled injection, ask the doctor for ways to become compliant or for another method of contraception which will suit the patient better.
For contraception and menorrhagia: A single vial [150 mg of Medroxyprogesterone Acetate (LYNDAVEL) in 1 mL suspension] within the first seven days of cycle or within first four weeks after giving birth (delay until six weeks after giving birth if breastfeeding). The patient can also have it injected any day as long as the patient is not pregnant and be sure to use a back up method such as a condom for the next seven days as a precaution to avoid pregnancy.
For secondary amenorrhea: 5 to 10 mg daily by intramuscular injection for about five to ten days until two days before the anticipated onset of menstruation.
For mild to moderate endometriosis: 50 mg weekly or 100 mg every two weeks by intramuscular injection for at least six months.
As follows are the steps in using Medroxyprogesterone Acetate (LYNDAVEL): 1. Wash hands with soap and water. If injection site is dirty, wash it with soap and water.
2. Gently shake the vial. If vial is cold, warm to skin temperature before giving the injection.
3. Pierce top of vial with sterile needle and fill syringe with proper dose.
4. Insert sterile needle deep into the hip (ventrogluteal muscle), the upper arm, (deltoid muscle), or the buttocks (gluteal muscle, upper outer portion), whichever the woman prefers. Inject the contents of the syringe. Do not massage the injection site. This could cause Medroxyprogesterone Acetate (LYNDAVEL) to be absorbed too fast.
5. Used disposable syringe and needle must be properly disposed by placing in a puncture-proof container.
6. The next injection can be administered two weeks before or four weeks after the scheduled day.
Missed Dose: For effective prevention of pregnancy, the patient must return. to the doctor every three months for the next injection. The next injection can be given two weeks before or 4 weeks after the scheduled day of the injection.
If the patient is less than 4 weeks late for the repeat injection, the doctor may give the next injection. The patient will not need a back-up contraceptive method, such as a condom for the next 7 days.
If the patient is more than 4 weeks late for the repeat injections, the patient can receive the next dose as long as the patient has not had sex since 2 weeks after the scheduled date of the injection or if the patient is reasonably certain that she is not pregnant; and the patient will need a back-up contraceptive method such as condom for the next 7 days after the injection.
If the patient keeps forgetting to return for the scheduled injection, ask the doctor for ways to become compliant or for another method of contraception which will suit the patient better.
Overdosage
No serious ill effects have been reported, although nausea and irregular bleeding may occur when patient used large doses over a long period of time.
If patient has taken more than the recommended dosage, consult a doctor immediately.
If patient has taken more than the recommended dosage, consult a doctor immediately.
Contraindications
Make sure the patient is not pregnant before the administration of Medroxyprogesterone Acetate (LYNDAVEL). The patient should inform the healthcare provider immediately if the patient has the following conditions before the administration of Medroxyprogesterone Acetate (LYNDAVEL): vaginal bleeding; possible pregnancy; history or current high risk of arterial disease; hormone-dependent neoplasms; hepatic impairment especially if severe; porphyria; after recent evacuation of hydatidiform mole.
Special Precautions
Regular consultation with a healthcare provider is recommended while using Medroxyprogesterone Acetate (LYNDAVEL). Inform the healthcare provider if the patient is suffering from the following conditions: cardiac or renal impairment; epilepsy; asthma; past ectopic pregnancy; history of depression; diabetes mellitus; hypertension; migraine; thromboembolism; other conditions which may be aggravated by fluid retention; conditions that cause significant decrease in bone mineral density that may lead to osteoporotic fractures.
Breastfeeding women should wait six weeks after giving birth before the administration of Medroxyprogesterone Acetate (LYNDAVEL).
Breastfeeding women should wait six weeks after giving birth before the administration of Medroxyprogesterone Acetate (LYNDAVEL).
Adverse Reactions
Some women may experience side effects such as gastrointestinal disturbances, changes in appetite or weight, fluid retention, edema, acne, chloasma (melasma), allergic skin rashes, urticaria, mental depression, breast changes including discomfort or occasionally gynecomastia, changes in libido, hair loss, hirsutism, fatigue, drowsiness, insomnia, fever, headache, premenstrual syndrome-like symptoms, altered menstrual cycles or irregular menstrual bleeding, anaphylaxis or anaphylactoid reaction (rarely) and injection site reactions. Alterations in serum lipid profile may occur, and rarely alterations in liver functions test and jaundice.
Drug Interactions
Taking aminoglutethimide markedly reduces the plasma concentrations of Medroxyprogesterone Acetate (LYNDAVEL), possibly through hepatic enzyme-inducing effect. An increase in the dose of Medroxyprogesterone Acetate (LYNDAVEL) is likely to be required.
Medroxyprogesterone Acetate (LYNDAVEL) can influence diabetic control. Adjustment in antidiabetic dosage could be required.
Medroxyprogesterone Acetate (LYNDAVEL) may inhibit ciclosporin metabolism leading to increase plasma-ciclosporin concentration and a risk of toxicity.
Medroxyprogesterone Acetate (LYNDAVEL) can influence diabetic control. Adjustment in antidiabetic dosage could be required.
Medroxyprogesterone Acetate (LYNDAVEL) may inhibit ciclosporin metabolism leading to increase plasma-ciclosporin concentration and a risk of toxicity.
Storage
Store at temperatures not exceeding 30°C. Protect from light. Do not freeze.
Action
Pharmacotherapeutic group: Progestogens. ATC code: G03AC06.
Pharmacology: Pharmacodynamics: Medroxyprogesterone Acetate exerts anti-estrogenic, anti-androgenic and anti-gonadotrophic effects.
Mechanism of Action: Medroxyprogesterone Acetate (LYNDAVEL) works primarily by preventing the release of eggs from the ovaries (ovulation). Also, it prevents pregnancy by thickening and decreasing the quality of cervical mucus, an anti-estrogen effect that prevents sperm penetration.
Pharmacokinetics: Parenteral Medroxyprogesterone Acetate (MPA) is a long acting progestational steroid. The long duration of action results from its slow absorption from the injection site. Immediately after injection of 150 mg MPA, plasma levels were 1.7 ± 0.3 nmol/l. Two weeks later, levels were 6.8 ± 0.8 nmol/l. Concentrations fell to the initial levels by the end of 12 weeks. At lower doses, plasma levels of MPA appear directly related to the dose administered. Serum accumulation over time was not demonstrated. MPA is eliminated via fecal and urinary excretion. Plasma half-life is about six weeks after a single intramuscular injection. At least 11 metabolites have been reported. And almost all are excreted in the urine.
Pharmacology: Pharmacodynamics: Medroxyprogesterone Acetate exerts anti-estrogenic, anti-androgenic and anti-gonadotrophic effects.
Mechanism of Action: Medroxyprogesterone Acetate (LYNDAVEL) works primarily by preventing the release of eggs from the ovaries (ovulation). Also, it prevents pregnancy by thickening and decreasing the quality of cervical mucus, an anti-estrogen effect that prevents sperm penetration.
Pharmacokinetics: Parenteral Medroxyprogesterone Acetate (MPA) is a long acting progestational steroid. The long duration of action results from its slow absorption from the injection site. Immediately after injection of 150 mg MPA, plasma levels were 1.7 ± 0.3 nmol/l. Two weeks later, levels were 6.8 ± 0.8 nmol/l. Concentrations fell to the initial levels by the end of 12 weeks. At lower doses, plasma levels of MPA appear directly related to the dose administered. Serum accumulation over time was not demonstrated. MPA is eliminated via fecal and urinary excretion. Plasma half-life is about six weeks after a single intramuscular injection. At least 11 metabolites have been reported. And almost all are excreted in the urine.
MedsGo Class
Depot Contraceptives / Oestrogens, Progesterones & Related Synthetic Drugs
Features
Brand
Lyndavel
Full Details
Dosage Strength
150 mg / ml
Drug Ingredients
- Medroxyprogesterone Acetate
Drug Packaging
Suspension for Injection (I.M.) 1ml x 25's
Generic Name
Medroxyprogesterone Acetate
Dosage Form
Suspension For Injection (I.M.)
Registration Number
DRP-338
Drug Classification
Prescription Drug (RX)
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