Primogyn Dosage

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• Dosage of Primogyn in details
• Primogyn interactions
• Primogyn reviews

Dosage of Primogyn in details

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin.

Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause

Start therapy with 0.025 mg per day applied to the skin once weekly. Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.

Treatment Of Moderate To Severe Symptoms Of Vulvar And Vaginal Atrophy Due To Menopause

Start therapy with 0.025 mg per day applied to the skin once weekly. Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.

Treatment Of Hypoestrogenism Due To Hypogonadism, Castration, Or Primary Ovarian Failure

Start therapy with 0.025 mg per day applied to the skin once weekly. The dose should be adjusted as necessary to control symptoms. Clinical responses (relief of symptoms) at the lowest effective dose should be the guide for establishing administration of the Primogyn transdermal system, especially in women with an intact uterus.

Prevention Of Postmenopausal Osteoporosis

Start therapy with 0.025 mg per day applied to the skin once weekly.

Application Of The Primogyn Transdermal System

Site Selection

• The adhesive side of Primogyn should be placed on a clean, dry area of the lower abdomen or the upper quadrant of the buttock.
• Primogyn should not be applied to or near the breasts.
• The sites of application must be rotated, with an interval of at least 1-week allowed between applications to the same site.
• The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub the transdermal system off.
• Application to areas where sitting would dislodge Primogyn should also be avoided.

Application

• Primogyn should be applied immediately after opening the pouch and removing the protective liner.
• Primogyn should be pressed firmly in place with the fingers for at least 10 seconds, making sure there is good contact, especially around the edges.
• If the system lifts, apply pressure to maintain adhesion.
• In the event that a system should fall off reapply it to a different location. If the system cannot be reapplied, a new system should be applied for the remainder of the 7-day dosing interval.
• Only one system should be worn at any one time during the 7-day dosing interval.
• Swimming, bathing, or using a sauna while using Primogyn has not been studied, and these activities may decrease the adhesion of the system and the delivery of Primogyn.

Removal Of The Primogyn Transdermal System

• Removal of Primogyn should be done carefully and slowly to avoid irritation of the skin.
• Should any adhesive remain on the skin after removal of the Primogyn system, allow the area to dry for 15 minutes. Then gently rubbing the area with an oil-based cream or lotion should remove the adhesive residue.
• Used patches still contain some active hormones. Each patch should be carefully folded in half so that it sticks to itself before throwing it away.

How supplied

Dosage Forms And Strengths

• Primogyn (Primogyn transdermal system), 0.025 mg per day—each 6.5 cm² system contains 2 mg of Primogyn
• Primogyn (Primogyn transdermal system), 0.0375 mg per day—each 9.375 cm² system contains 2.85 mg of Primogyn
• Primogyn (Primogyn transdermal system), 0.05 mg per day—each 12.5 cm² system contains 3.8 mg of Primogyn
• Primogyn (Primogyn transdermal system), 0.060 mg per day—each 15 cm² system contains 4.55 mg of Primogyn
• Primogyn (Primogyn transdermal system), 0.075 mg per day—each 18.75 cm² system contains 5.7 mg of Primogyn
• Primogyn (Primogyn transdermal system), 0.1 mg per day—each 25.0 cm² system contains 7.6 mg of Primogyn

Primogyn (Primogyn transdermal system), 0.025 mg per day — each 6.5 cm² system contains 2 mg of Primogyn USP Individual Carton of 4 systems NDC 50419-454-04

Primogyn (Primogyn transdermal system), 0.0375 mg per day — each 9.375 cm² system contains 2.85 mg of Primogyn USP Individual Carton of 4 systems NDC 50419-456-04

Primogyn (Primogyn transdermal system), 0.05 mg per day — each 12.5 cm² system contains 3.8 mg of Primogyn USP Individual Carton of 4 systems NDC 50419-451-04

Primogyn (Primogyn transdermal system), 0.06 mg per day — each 15 cm² system contains 4.55 mg of Primogyn USP Individual Carton of 4 systems NDC 50419-459-04

Primogyn (Primogyn transdermal system), 0.075 mg per day — each 18.75 cm² system contains 5.7 mg of Primogyn USP Individual Carton of 4 systems NDC 50419-453-04

Primogyn (Primogyn transdermal system), 0.1 mg per day — each 25 cm² system contains 7.6 mg of Primogyn USP Individual Carton of 4 systems NDC 50419-452-04

Storage And Handling

Store at 20°C to 25°C (66°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Do not store above 86°F (30°C).

Do not store unpouched. Apply immediately upon removal from the protective pouch.

Used transdermal systems still contain active hormone. To discard, fold the sticky side of the transdermal system together, place it in a sturdy child-proof container, and place this container in the trash. Used transdermal systems should not be flushed in the toilet.

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981. Manufactured by 3M Drug Delivery Systems, Northridge, CA 91324. Revised: Oct 2013

What other drugs will affect Primogyn?

Before using Primogyn, tell your doctor if you are taking any of the following medicines:

• an anticoagulant (blood thinner) such as warfarin (Coumadin);

• a thyroid medication such as levothyroxine (Synthroid, Levoxyl, Levothroid, and others);

• insulin or an oral diabetes medicine such as glipizide (Glucotrol), glyburide (Diabeta, Micronase), and others; or

• tamoxifen (Nolvadex).

A dosage adjustment or special monitoring may be required during treatment if you are taking any of the medicines listed above.

Do not use other vaginal products at the same times as Primogyn without first talking to your doctor.

Drugs other than those listed here may also interact with Primogyn. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Primogyn interactions

CYP3A4 Interaction

Primogyn is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A4. Potent inhibitors of CYP3A4 (below) increase the risk of myopathy by reducing the elimination of lovastatin

Pharmacokinetics Itraconazol Ketoconazol Erythromyci Clarithromyci Telithromyci HIV protease inhibitor Nefazodon Cyclosporin Large quantities of grapefruit juice (>1 quart daily

Interactions with lipid-lowering drugs that can cause myopathy when given alone

The risk of myopathy is also increased by the following lipid-lowering drugs that are not potent CYP3A4 inhibitors, but which can cause myopathy when given alone

See WARNINGS, Myopathy/Rhabdomyolysis Gemfibrozi Other fibrate Niacin (nicotinic acid) (=1 g/day

Other drug interaction

Danazol: The risk of myopathy/rhabdomyolysis is increased by concomitant administration of danazol particularly with higher doses of lovastatin

Amiodarone or Verapamil: The risk of myopathy/rhabdomyolysis is increased when either amiodarone or verapamil is used concomitantly with a closely related member of the HMG-CoA reductase inhibitor class

Coumarin Anticoagulants: In a small clinical trial in which lovastatin was administered to warfarin treated patients, no effect on prothrombin time was detected. However, another HMG-CoA reductase inhibitor has been found to produce a less than two-second increase in prothrombin time in healthy volunteers receiving low doses of warfarin. Also, bleeding and/or increased prothrombin time have been reported in a few patients taking coumarin anticoagulants concomitantly with lovastatin. It is recommended that in patients taking anticoagulants, prothrombin time be determined before starting lovastatin and frequently enough during early therapy to insure that no significant alteration of prothrombin time occurs Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on coumarin anticoagulants. If the dose of lovastatin is changed, the same procedure should be repeated. Primogyn therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants

Propranolol: In normal volunteers, there was no clinically significant pharmacokinetic o pharmacodynamic interaction with concomitant administration of single doses of lovastatin and propranolol

Digoxin: In patients with hypercholesterolemia, concomitant administration of lovastatin and digoxin resulted in no effect on digoxin plasma concentrations

Oral Hypoglycemic Agents: In pharmacokinetic studies of MEVACOR in hypercholesterolemic noninsulin dependent diabetic patients, there was no drug interaction with glipizide or with chlorpropamide

References

1. DailyMed. "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DailyMed. "ESTRADIOL HEMIHYDRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
3. FDA/SPL Indexing Data. "4TI98Z838E: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology