Oxyprogesterone capro- nate (Oxyprogesteroni caproas)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHydroxyprogesterone caproateHydroxyprogesterone caproate
Dosage form: & nbspsolution for intramuscular administration oily.
Composition:
Active substance: hydroxyprogesterone caproate-125 mg.
Excipients: benzyl benzoate medical - 300 μl, olive oil - up to 1 ml.
Description:Transparent oily liquid of light yellow or golden yellow color.
Pharmacotherapeutic group:gestagen
ATX: & nbsp

G.03.D.A.03   Hydroxyprogesterone

Pharmacodynamics:
Synthetic analogue of the hormone of the yellow body (progesterone). Chemically different from progesterone in that in position 17 contains the residue of caproic acid. Being a hydroxyprogesterone ester, it is metabolized more slowly than progesterone (it has a longer action). After a single intramuscular injection of an oily solution, its effect lasts from 7 to 14 days. On biological properties similar to progesterone. By binding to receptors on the surface of the cells of target organs, it penetrates into the nucleus, where, by controlling the transcription of DNA, it affects the synthesis of RNA.It facilitates the transition of the mucous membrane of the uterus phase proliferation caused by follicle stimulating hormone in secretion, and after fertilization creates the necessary conditions for the development and implantation of a fertilized egg. Reduces the excitability and contractility of the muscles of the uterus and fallopian tubes, stimulates the development of the alveoli (molokoobrazuyuschih departments) of the mammary glands.
Pharmacokinetics:Quickly and almost completely absorbed after intramuscular injection. Metabolized in the liver with the formation of conjugates with glucuronic and sulfuric acids. The half-life is 5 minutes. It is excreted by the kidneys - 50-60%, with bile - more than 10%. The amount of metabolites excreted by the kidneys varies depending on the phase of the yellow body.
Indications:Conditions associated with corpus luteum insufficiency: amenorrhea (primary and secondary), dysfunctional uterine bleeding.
Contraindications:Hypersensitivity to the drug, hepatitis, liver failure, breast cancer and genital organs, the tendency to thrombosis, children up to 15 years, the second half of pregnancy.
Carefully:
With diseases of the cardiovascular system, arterial hypertension, chronic renal failure, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression, hyperlipoproteinemia.
Treatment is often combined with the appointment of estrogen drugs or carried out directly after estrogen therapy.
Pregnancy and lactation:The drug is not used during pregnancy. In the case of pregnancy on the background of the drug should be immediately interrupted treatment; there is no data on the necessity of abortion. The drug is contraindicated in the second half of pregnancy and during breastfeeding.
Dosing and Administration:
Method of administration: intramuscularly. Before administration, the preparation should be heated to 30-40 ° C. In amenorrhea (primary, secondary) is appointed immediately after the termination of the use of estrogenic medicines of 250 mg once or in two administrations.
To treat dysfunctional uterine bleeding, the drug is less convenient than progesterone, t. its effect is slow, but it can be used to normalize the cycle 62.5-125 mg (0.5-1 ml) on the 20-22 day of the cycle.
Side effects:
From the nervous system: drowsiness, headache, depression, apathy, dysphoria.
From the digestive system: Cholestatic hepatitis, nausea, vomiting, decreased appetite, calculous cholecystitis.
From the genitourinary system: decreased libido, menstrual irregularities.
From the sense organs: impaired vision.
From the cardiovascular system: increased blood pressure, peripheral edema, thromboembolism (including pulmonary arteries and cerebral vessels), thrombophlebitis, retinal vein thrombosis.
From the endocrine system: galactorrhea, alopecia, weight gain, increase, pain and tension of the mammary glands, hirsutism.
Allergic reactions.
Local reactions: pain in the injection site.
Overdose:
Symptoms: oppression of the central nervous system, drowsiness, tachycardia; increased blood pressure, weakness, sweating.
Treatment: cessation of therapy until the disappearance of symptoms, with subsequent prescription, smaller doses. If necessary, perform symptomatic treatment.
Interaction:
Weaken the effect of drugs that stimulate the reduction of myometrium (oxytropin), anabolic steroids (nandrolone), gonadotropic hormones of the pituitary gland.
Strengthens the action of diuretics, hypotensive drugs, immunosuppressants, bromocriptine. Reduces the effectiveness of anticoagulants.
The gestagenic activity of the drug is reduced by inducers of microsomal oxidation (barbiturates, hydantoins, rifampicin and etc.).
Special instructions:
In the case of crystal precipitation or crystallization of the entire contents of the ampoule, the ampoule should be heated in a boiling water bath with shaking. If the crystals disappear and the solution becomes transparent, and upon cooling to 36-38 ° C the crystals do not fall again, the solution is suitable for use.
The administration of the drug should be performed only by the attending physician, under his supervision after an accurate diagnosis.
In the treatment of amenorrhea in children, it is necessary first of all to verify the diagnosis of amenorrhea. Treatment before the pubertal period should be aimed at stimulating growth. After 15-17 years, it is possible to carry out substitution therapy with estrogens and gestagens, which causes cyclic, uterine bleeding.
Effect on the ability to drive transp. cf. and fur:Care should be taken when driving vehicles and engaging in other potentially hazardous activities,requiring increased concentration and speed of psychomotor reactions, since the drug can cause side effects that can affect these abilities.
Form release / dosage:
Solution for intramuscular administration oily 125 mg / ml.
Packaging:
1 ml per ampoule of neutral glass. 10 ampoules, together with the instruction for use and the ampoule opening knife or the ampoule scarifier, are placed in a carton box of 5 ampoules into a contour cell box made of a polyvinyl chloride film. 2 contoured cell packs together with the instruction for use and a knife for the opened ampoule or the ampoule scarifier are placed in a pack of cardboard.
When using ampoules with notches, rings and break points, a scarifier ampoule or a knife for an open ampoule is allowed not to be put.
Storage conditions:
Store in a dark place at a temperature of 5 to 25 ° C.
Keep out of the reach of children.
Shelf life:
5 years. Do not use after the expiration date printed on the package.
Terms of leave from pharmacies:On prescription
Registration number:PL-000881
Date of registration:18.10.2011
The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia
Manufacturer: & nbsp
Information update date: & nbsp29.12.2015
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