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DEPO-PROVERA is a brand name for Medroxyprogesterone (also known as Medroxyprogesterone Acetate). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Progestogen: for contraception. Depo-Provera is indicated for long-term female contraception. Each injection prevents ovulation and provides contraception for at least 12 weeks (+/- 5 days). However, it should be taken into consideration that the return to fertility (ovulation) may be delayed for up to one year (see…
Verbatim from this product's MHRA label. Tap a section to expand.
m. should be given during the first five days of a normal menstrual cycle. If the injection is carried out according to these instructions, no additional contraceptive cover is required.
Post Partum:
To increase assurance that the patient is not pregnant at the time of first administration, this injection should be given within 5 days post partum if not breast- feeding. There is evidence that women prescribed Depo-Provera in the immediate puerperium can experience prolonged and heavy bleeding.
Because of this, the drug should be used with caution in the puerperium. Women who are considering use of the product immediately following delivery or termination should be advised that the risk of heavy or prolonged bleeding may be increased.
Doctors are reminded that in the non breast-feeding, post partum patient, ovulation may occur as early as week 4. If the puerperal woman will be breast-feeding, the initial injection should be given no sooner than six weeks post partum, when the infant's enzyme system is more fully developed.
Further injections should be given at 12 week intervals. g. barrier) are required. B. M. g. barrier) for fourteen days after this subsequent injection.
Elderly:
Not appropriate. 1 Therapeutic Indications). Data in adolescent females (12-18 years) is available for IM administration of medroxyprogesterone acetate (MPA) (see Section
The table below provides a listing of adverse drug reactions with frequency based on all-causality data from clinical studies that enrolled more than 4200 women who received DMPA for contraception for up to 7 years. Those most frequently (>5%) reported adverse drug reactions were weight increased (69%), weight decreased (25%), headache (16%), nervousness (11%), abdominal pain or discomfort (11%), dizziness (6%), and decrease in libido (6%).
The following lists of adverse reactions are listed within the organ system classes, under headings of frequency (number of patients expected to experience the reaction), using the following categories: Very common (≥1/10) Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data) System Organ Class Very Common ≥1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1000 to < 1/100 Rare ≥ 1/10,000 to < 1/1000 Not known (cannot be estimated from the available data) Neoplasms Benign, Malignant and Unspecified (Incl.
Cysts and Polyps) Breast cancer Meningioma Blood and lymphatic system disorders Anaemia, Blood disorder Immune system disorders Drug hypersensitivit y Anaphylactic reaction, Anaphylactoid reaction, Angioedema Metabolism & Nutrition Disorder Increased appetite, decreased appetite Psychiatric disorders Nervousness Depression, Libido decreased Insomnia Anorgasmia, Emotional disturbance, Effective disorder, Irritability, Anxiety System Organ Class Very Common ≥1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1000 to < 1/100 Rare ≥ 1/10,000 to < 1/1000 Not known (cannot be estimated from the available data) Nervous system disorders Headache Dizziness Seizure, Somnolence, Paraesthesia Migraine, Paralysis, Syncope Ear and Labyrinth Disorder Vertigo Cardiac disorder Tachycardia Vascular disorders Hot flush Embolism and thrombosis, Deep vein thrombosis, Thrombophlebi tis, Hypertension, Varicose veins Respiratory, thoracic, and mediastinal disorders Dyspnoea Pulmonary embolism Gastrointestinal disorders Abdominal pain, Abdominal discomfort Nausea, Abdominal distension Rectal haemorrhage, Gastrointestina l disorder Hepatobiliary disorders Hepatic function abnormal Jaundice, Hepatic enzyme abnormal Skin and subcutaneous tissue disorders Alopecia, Acne, Rash Hirsutism, Urticaria, Pruritus, Chloasma Lipodystrophy acquired*, Dermatitis, Ecchymosis, Scleroderma, Skin striae Musculoskeletal and connective tissue disorders Back pain, Pain in extremity Arthralgia, Muscle spasms, Osteoporosis, Osteoporotic fractures System Organ Class Very Common ≥1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1000 to < 1/100 Rare ≥ 1/10,000 to < 1/1000 Not known (cannot be estimated from the available data) Reproductive system and breast disorders Vaginal discharge, Breast tenderness, Dysmenorrhea , Genitourinary tract infection Dysfunctional uterine bleeding (irregular, increase, decrease, spotting, Galactorrhoea Pelvic pain, Dyspareunia, Suppressed lactation Vaginitis, Amenorrhoea, Breast pain, Metrorrhagia, Menometrorrh agia, Menorrhagia, Vulvovaginal dryness, Breast atropy, Ovarian cyst, Premenstrual syndrome, Endometrial hyperplasia, Breast mass, Nipple exudate bloody, Vaginal cyst, Breast enlargement, Lack of return to fertility, Sensation of pregnancy General disorders and administration site conditions Odema/Fluid retention, Asthenia Chest pain Pyrexia, Fatigue, Injection site reaction*, Injection site persistent atrophy/indent ation/dimpling *, Injection site nodule/lump*, Injection site pain/tenderness * Thirst, Dysphonia, VIIth nerve paralysis, Axillary swelling System Organ Class Very Common ≥1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1000 to < 1/100 Rare ≥ 1/10,000 to < 1/1000 Not known (cannot be estimated from the available data) Investigation Weight increased, Weight decreased Bone density decreased, Glucose tolerance decreased, Cervical smear abnormal *ADR identified post-marketing Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
1 Pharmacodynamic properties). Other than concerns about loss of BMD, the safety and effectiveness of Depo-Provera is expected to be the same for adolescents after menarche and adult females. Switching from other Methods of Contraception Depo-Provera should be given in a manner that ensures continuous contraceptive coverage.
g. patients switching from oral contraceptives should have their first injection of Depo- provera within 7 days of taking their last active pill). Hepatic Insufficiency The effect of hepatic disease on the pharmacokinetics of Depo-Provera is unknown.
3). Renal Insufficiency The effect of renal disease on the pharmacokinetics of Depo-Provera is unknown. No dosage adjustment should be necessary in women with renal insufficiency, since Depo-Provera is almost exclusively eliminated by hepatic metabolism.
Method of Administration The sterile aqueous suspension of Depo-Provera should be vigorously shaken just before use to ensure that the dose being given represents a uniform suspension of Depo-Provera. Doses should be given by deep intramuscular injection.
Care should be taken to ensure that the depot injection is given into the muscle tissue, preferably the gluteus maximus, but other muscle tissue such as the deltoid may be used. The site of injection should be cleansed using standard methods prior to administration of the injection.
1. Depo-Provera should not be used during pregnancy, either for diagnosis or therapy. Depo-Provera is contraindicated as a contraceptive at the above dosage in known or suspected hormone-dependent malignancy of breast or genital organs.
Depo-Provera is contraindicated in patients with the presence or history of severe hepatic disease whose liver function tests have not returned to normal. Whether administered alone or in combination with oestrogen, Depo-Provera should not be employed in patients with abnormal uterine bleeding until a definite diagnosis has been established and the possibility of genital tract malignancy eliminated.
1. Depo-Provera should not be used during pregnancy, either for diagnosis or therapy. Depo-Provera is contraindicated as a contraceptive at the above dosage in known or suspected hormone-dependent malignancy of breast or genital organs.
Depo-Provera is contraindicated in patients with the presence or history of severe hepatic disease whose liver function tests have not returned to normal. Whether administered alone or in combination with oestrogen, Depo-Provera should not be employed in patients with abnormal uterine bleeding until a definite diagnosis has been established and the possibility of genital tract malignancy eliminated.
Depo-Provera is contraindicated in patients with meningioma or history of meningioma.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Depo-Provera is contraindicated in patients with meningioma or history of meningioma. 4 Special warnings and precautions for use Assessment of women prior to starting hormonal contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman.
4) for this product. The frequency and nature of these assessments should be based upon relevant guidelines and should be adapted to the individual woman, but should include measurement of blood pressure and, if judged appropriate by the clinician, breast, abdominal and pelvic examination including cervical cytology.
Loss of Bone Mineral Density:
Use of depot medroxyprogesterone acetate intramuscular (DMPA-IM) reduces serum oestrogen levels and is associated with significant loss of BMD due to the known effect of oestrogen deficiency on the bone remodelling system. Bone loss is greater with increasing duration of use; however BMD appears to increase after DMPA-IM is discontinued and ovarian oestrogen production increases.
This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. e. after menopause. A study to assess the BMD effects of DMPA-IM (Depo-Provera) in adolescent females showed that its use was associated with a statistically significant decline in BMD from baseline.
1). However in some participants, BMD did not fully return to baseline during follow-up and the long-term outcome is not known in this group. In adolescents, Depo-Provera may be used, but only after other methods of contraception have been discussed with the patients and considered to be unsuitable or unacceptable.
A large observational study of predominantly adult female contraceptive users showed that use of DMPA-IM did not increase risk for bone fractures. 1 – Relationship of fracture incidence to use of DMPA-IM by women of reproductive age).
In women of all ages, careful re-evaluation of the risks and benefits of treatment should be carried out in those who wish to continue use for more than 2 years. In particular, in women with significant lifestyle and/or medical risk factors for osteoporosis, other methods of contraception should be considered prior to use of Depo-Provera.
g. g. 1. Adequate intake of calcium and Vitamin D, whether from the diet or from supplements, is important for bone health in women of all ages.
Menstrual Irregularity:
The administration of Depo-Provera usually causes disruption of the normal menstrual cycle. Bleeding patterns include amenorrhoea (present in up to 30% of women during the first 3 months and increasing to 55% by month 12 and 68% by month 24); irregular bleeding and […]