Delalutin

Delalutin Medicine

Contraindications

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What is the most important information I should know about Delalutin?

Delalutin is contraindicated in patients with known or suspected carcinoma of the breast, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding; liver dysfunction or disease; missed abortion, and in those with a history of hypersensitivity to the drug. Delalutin is also contraindicated as a diagnostic test for pregnancy and in patients with current or history of thrombotic or thromboembolic disorders.

Undesirable effects

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What are the possible side effects of Delalutin?

Applies to Delalutin: intramuscular oil, intramuscular solution

In addition to its needed effects, some unwanted effects may be caused by Delalutin (the active ingredient contained in Delalutin). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking Delalutin, check with your doctor or nurse immediately:

More common:

  • Pain, itching, or swelling at the injection site
Less common:
  • Small lumps at the injection site
Incidence not known:
  • Anxiety
  • chest pain
  • cough
  • dizziness or lightheadedness
  • fainting
  • fast heartbeat
  • redness, tenderness, or warmth on the skin
  • sudden shortness of breath or troubled breathing
Minor Side Effects

Some of the side effects that can occur with Delalutin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

  • Hives or welts
  • itching
  • nausea
  • skin rash
Less common:
  • Diarrhea

Therapeutic indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Delalutin Injection USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation.

Delalutin is a form of progestin, a manmade form of a female hormone called Delalutin.

Delalutin is used to lower the risk of premature birth in a woman who has already had one premature baby. This medication will not stop premature labor that has already begun.

Delalutin is not for use in women who have had more than one pregnancy.

Delalutin may also be used for purposes not listed in this medication guide.

Name of the medicinal product

Delalutin

Qualitative and quantitative composition

The major progestational steroid that is secreted primarily by the corpus luteum and the placenta. Delalutin acts on the uterus, the mammary glands and the brain. It is required in embryo implantation; pregnancy maintenance, and the development of mammary tissue for milk production. Delalutin, converted from pregnenolone, also serves as an intermediate in the biosynthesis of gonadal steroid hormones and adrenal corticosteroids.

Special warnings and precautions for use

Use Delalutin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Delalutin. Talk to your pharmacist if you have questions about this information.
  • Delalutin is usually given as an injection every 7 days at your doctor's office, hospital, or clinic.
  • Delalutin should appear as a clear, yellow solution. Do not use Delalutin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Delalutin, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Delalutin.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Delalutin is used to reduce risk of preterm birth (delivery in <37 weeks of pregnancy) in women pregnant with one baby (singleton pregnancy) and who have delivered a premature baby in the past.

Dosage (Posology) and method of administration

Suggested dosages are presented in the therapy guide.

Because of the low viscosity of the vehicle, Delalutin Injection may be administered with a small gauge needle. Care should be taken to inject the preparation deeply into the upper outer quadrant of the gluteal muscle following the usual precautions for intramuscular injection. Since the 250 mg potency provides a high concentration in a small volume, particular care should be observed to administer the full dose.

Note: Use of a wet needle or syringe may cause the solution to become cloudy; however, this does not affect the potency of the material.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Protect from light. Store vial in its box. Store upright. Discard any unused product within 28 days after first use.

Interaction with other medicinal products and other forms of interaction

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What other drugs will affect Delalutin?

Drug/Laboratory Test Interactions

The following laboratory results may be altered by the use of estrogen-progestin combination drugs:

  • Increased sulfobromophthalein retention and other hepatic function tests.
  • Coagulation tests: increase in prothrombin factors VII, VIII, IX and X.
  • Metyrapone test.
  • Pregnanediol determination.
  • Thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T3 uptake values.

Fasting and 2-hour plasma insulin and glucose levels following an oral glucose tolerance test (OGTT) and figrinogen levels were measured in patients receiving PROMETRIUM® Capsules at a dose of 200 mg/day for 12 days per 28 day cycle in combination with conjugated estrogens 0.625 mg/day (n-120). Table 6 summarizes this data. Plasma insulin levels 2 hours post-OGTT were decreased from baseline. The fasting plasma glucose and fasting plasma insulin levels were also decreased from baseline. Glucose levels 2 hours post-OGTT were increased slightly. There was no effect on fibrinogen levels.

For information on changes in lipid profile, see the CLINICAL PHARMACOLOGY, Clinical Studies subsection, Table 5.

Table 6