Planovar Uses

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How do you administer this medicine?

What is Planovar?

Lo/Planovar-28 contains a combination of ethinyl estradiol and Norgestrel (Planovar). Ethinyl estradiol and Norgestrel (Planovar) are female hormones that prevent ovulation (the release of an egg from an ovary). Lo/Planovar-28 also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Lo/Planovar-28 is used as contraception to prevent pregnancy.

Lo/Planovar-28 may also be used for purposes not listed in this medication guide.

Planovar indications

infoAn 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.
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Planovar (Norgestrel (Planovar) and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.1 The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD
NA – not available
*Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition. NY, NY: Ardent Media, Inc., 1998
Method Perfect Use Typical Use
Levonorgestrel implants 0.05 0.05
Male sterilization 0.1 0.15
Female sterilization 0.5 0.5
Depo-Provera®

(injectable progestogen)

0.3 0.3

Oral contraceptives

5
Combined 0.1 NA
Progestin only 0.5 NA
IUD
Progesterone 1.5 2.0
Copper T 380A 0.6 0.8
Condom (male) without spermicide 3 14
(Female) without spermicide 5 21
Cervical cap
Nulliparous women 9 20
Parous women 26 40
Vaginal sponge
Nulliparous women 9 20
Parous women 20 40
Diaphragm with

spermicidal cream or jelly

6 20
Spermicides alone

(foam, creams, jellies, and vaginal suppositories)

6 26
Periodic abstinence (all methods) 1-9* 25
Withdrawal 4 19
No contraception (planned pregnancy) 85 85

Planovar description

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A synthetic progestational hormone with actions similar to those of progesterone and about twice as potent as its racemic or (+-)-isomer (Norgestrel (Planovar)). It is used for contraception, control of menstrual disorders, and treatment of endometriosis.

Planovar dosage

To achieve maximum contraceptive effectiveness, Planovar® must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Planovar® is one white tablet daily for 21 consecutive days, followed by one light-green inert tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that tablets be taken at the same time each day, preferably after the evening meal or at bedtime.

During the first cycle of medication, the patient is instructed to begin taking Planovar® on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days followed by one light-green inert tablet daily for 7 consecutive days.

Withdrawal bleeding should usually occur within three days following discontinuation of white tablets. During the first cycle, contraceptive reliance should not be placed on Planovar® until a white tablet has been taken daily for 7 consecutive days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient begins her next and all subsequent 28 day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days on white tablets – 7 days on light-green inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself by using another method of birth control until she has taken a white tablet daily for 7 consecutive days.

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician.

Although the occurrence of pregnancy is highly unlikely if Planovar® is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

For additional patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the DETAILED PATIENT LABELING below.

Any time the patient misses two or more white tablets, she should also use another method of contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more light-green tablets, she is still protected against pregnancy provided she begins taking white tablets again on the proper day. If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. While there is little likelihood of ovulation occurring if only one or two tablets are missed, the possibility of ovulation increases with each successive day that scheduled white tablets are missed.

In the nonlactating mother, Planovar® may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. It is to be noted that early resumption of ovulation may occur if Parlodel® (bromocriptine mesylate) has been used for the prevention of lactation.

Planovar interactions

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What other drugs will affect Planovar?

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Changes in contraceptive effectiveness associated with coadministration of other products: Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin, and modafinil

Several cases of contraceptive failure and breakthrough bleeding have been reported in the literature with concomitant administration of antibiotics such as ampicillin and other penicillins, and tetracyclines, possibly due to a decrease of enterohepatic recirculation of estrogens

However, clinical pharmacology studies investigating drug interactions between combined oral contraceptives and these antibiotics have reported inconsistent results. Enterohepatic recirculation of estrogens may also be decreased by substances that reduce gut transit time

Several of the anti-HIV protease inhibitors have been studied with coadministration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of oral contraceptive products may be affected with coadministration of anti-HIV protease inhibitors. Health-care professionals should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information

Herbal products containing St. Johns Wort (Hypericum perforatum) may induce hepatic enzymes (cytochrome P 450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding

During concomitant use of ethinyl estradiol containing products and substances that may lead to decreased plasma steroid hormone concentrations, it is recommended that a nonhormonal backup method of birth control be used in addition to the regular intake of Lo/Planovar. If the use of a substance which leads to decreased ethinyl estradiol plasma concentrations is required for a prolonged period of time, combination oral contraceptives should not be considered the primary contraceptive

After discontinuation of substances that may lead to decreased ethinyl estradiol plasma concentrations, use of a nonhormonal back-up method of birth control is recommended for 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have led to induction of hepatic microsomal enzymes, resulting in decreased ethinyl estradiol concentrations. It may take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use, and rate of elimination of the inducing substance

Increase in plasma levels associated with coadministered drugs: Coadministration of atorvastatin and certain oral contraceptives containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. The mechanism of this interaction is unknown. Ascorbic acid and acetaminophen increase the bioavailability of ethinyl estradiol since these drugs act as competitive inhibitors for sulfation of ethinyl estradiol in the gastrointestinal wall, a known pathway of elimination for ethinyl estradiol. CYP 3A4 inhibitors such as indinavir, itraconazole, ketoconazole, fluconazole, and troleandomycin may increase plasma hormone levels. Troleandomycin may also increase the risk of intrahepatic cholestasis during coadministration with combination oral contraceptives

Changes in plasma levels of coadministered drugs: Combination hormonal contraceptives containing some synthetic estrogens (eg, ethinyl estradiol) may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporin, prednisolone and other corticosteroids, and theophylline have been reported with concomitant administration of oral contraceptives. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine, and clofibric acid, due to induction of conjugation (particularly glucuronidation), have been noted when these drugs were administered with oral contraceptives

Interactions With Laboratory Tests - Certain endocrine and liver-function tests and blood components may be affected by oral contraceptives

a. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability

b. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered

c. Other binding proteins may be elevated in serum ie, corticosteroid binding globulin (CBG), sex hormone-binding globulins (SHBG) leading to increased levels of total circulating corticosteroids and sex steroids respectively. Free or biologically active hormone concentrations are unchanged

d. Triglycerides may be increased and levels of various other lipids and lipoproteins may be affected

e. Glucose tolerance may be decreased

f. Serum folate levels may be depressed by oral-contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.

Planovar side effects

See also:
What are the possible side effects of Planovar?

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To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC, Toll-Free at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives section):

  • Thrombophlebitis
  • Arterial thromboembolism
  • Pulmonary embolism
  • Myocardial infarction
  • Cerebral hemorrhage
  • Cerebral thrombosis
  • Hypertension
  • Gallbladder disease
  • Hepatic adenomas, carcinomas or benign liver tumors

There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:

  • Mesenteric thrombosis
  • Retinal thrombosis

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

  • Nausea
  • Vomiting
  • Gastrointestinal symptoms (such as abdominal cramps and bloating)
  • Breakthrough bleeding
  • Spotting
  • Change in menstrual flow
  • Amenorrhea
  • Temporary infertility after discontinuation of treatment
  • Melasma which may persist
  • Breast changes: tenderness, enlargement, secretion
  • Change in weight (increase or decrease)
  • Change in cervical erosion and secretion
  • Diminution in lactation when given immediately postpartum
  • Cholestatic jaundice
  • Migraine
  • Rash (allergic)
  • Mental depression
  • Reduced tolerance to carbohydratesn
  • Vaginal candidiasis
  • Change in corneal curvature (steepening)
  • Intolerance to contact lenses

The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:

  • Pre-menstrual syndrome
  • Cataracts
  • Changes in appetite
  • Cystitis-like syndrome
  • Headache
  • Nervousness
  • Dizziness
  • Hirsutism
  • Loss of scalp hair
  • Erythema multiforme
  • Erythema nodosum
  • Hemorrhagic eruption
  • Vaginitis
  • Porphyria
  • Impaired renal function
  • Hemolytic uremic syndrome
  • Budd-Chiari syndrome
  • Acne
  • Changes in libido
  • Colitis

Planovar contraindications

See also:
What is the most important information I should know about Planovar?

Combination oral contraceptives should not be used in women with any of the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep-vein thrombophlebitis or thromboembolic disorders - Cerebral-vascular or coronary-artery disease (current or history) - Thrombogenic valvulopathies - Thrombogenic rhythm disorders - Major surgery with prolonged immobilization - Diabetes with vascular involvement - Headaches with focal neurological symptoms - Uncontrolled hypertension Known or suspected carcinoma of the breast or personal history of breast cancer - Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - Undiagnosed abnormal genital bleeding - Cholestatic jaundice of pregnancy or jaundice with prior pill use - Hepatic adenomas or carcinomas, or active liver disease, as long as liver function has not returned to normal - Known or suspected pregnancy - Hypersensitivity to any of the components of Lo/Planovar

Active ingredient matches for Planovar:

Ethinylestradiol/Norgestrel in Japan.


List of Planovar substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tablet; Oral-21; Ethinyl Estradiol 0.03 mg; Norgestrel 0.3 mg (Barr)
Tablet; Oral-28; Ethinyl Estradiol 0.03 mg; Norgestrel 0.3 mg (Barr)
Tablet; Oral; Levonorgestrel 0.75 mg (Hexal)
Tablet; Oral; Ethinyl Estradiol; Norgestrel (Tnp)
Jeny-FMP 28's (Tnp)
Norfem 21's
Tablet; Oral-21; Ethinyl Estradiol 0.05 mg; Norgestrel 0.25 mg (Wyeth Ltd.)
Tablet; Oral-21; Ethinyl Estradiol 0.05 mg; Norgestrel 0.5 mg (Wyeth Ltd.)
Tablet; Oral-28; Ethinyl Estradiol 0.05 mg; Norgestrel 0.25 mg (Wyeth Ltd.)
Tablet; Oral-28; Ethinyl Estradiol 0.05 mg; Norgestrel 0.5 mg (Wyeth Ltd.)
OVRAL Capsule/ Tablet / 0.05mg - 0.25mg / 21 units (Wyeth Ltd.)$ 0.79
Ovral Levonorgestrel 0.25mg, EthinylEstradiol 0.05mg TAB / 21 (Wyeth Ltd.)$ 0.59
21's (Wyeth Ltd.)$ 0.59
Ovral Levonorgestrel 0.25 mg, Ethinyl estradiol 0.05 mg. TAB / 21 (Wyeth Ltd.)$ 0.59
Ovral 0.25+0.05 Tablet (Wyeth Ltd.)$ 0.04
OVRAL TABLET 1 strip / 21 tablets each (Wyeth Ltd.)$ 1.12
OVRAL tab 21's (Wyeth Ltd.)$ 0.59
Ovral Tablet (Wyeth Ltd.)$ 0.05
Tablet; Oral-21; Ethinyl Estradiol 0.05 mg; Norgestrel 0.25 mg
Tablet; Oral-21; Ethinyl Estradiol 0.05 mg; Norgestrel 0.5 mg
Tablet; Oral-28; Ethinyl Estradiol 0.05 mg; Norgestrel 0.25 mg
Tablet; Oral-28; Ethinyl Estradiol 0.05 mg; Norgestrel 0.5 mg
Ovral-G Norgestrel 0.5mg, EthinylEstradiol 0.05mg TAB / 20 (Wyeth)$ 1.52
20's (Wyeth)$ 1.52
Ovral-G Norgestrel 0.5 mg, Ethinylestradiol 0.05 mg. TAB / 20 (Wyeth)$ 1.52
OVRAL-G tab 20's (Wyeth)$ 1.78
Tablet, Film-Coated; Oral; Ethinyl Estradiol 0.05 mg; Norgestrel 0.5 mg
Tablet, Film-Coated; Oral; Ethinyl Estradiol 0.05 mg; Norgestrel 0.5 mg

References

  1. DailyMed. "ETHINYL ESTRADIOL; NORGESTREL: 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. PubChem. "norgestrel". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "norgestrel". http://www.drugbank.ca/drugs/DB09389 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Planovar are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Planovar. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

Consumer reported useful

No survey data has been collected yet


1 consumer reported price estimates

Was the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by ndrugs.com website users about whether the Planovar drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Users%
Not expensive1
100.0%


3 consumers reported time for results

To what extent do I have to use Planovar before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 1 day and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Planovar. To get the time effectiveness of using Planovar drug by other patients, please click here.
Users%
1 day1
33.3%
2 days1
33.3%
1 week1
33.3%


2 consumers reported age

Users%
30-451
50.0%
16-291
50.0%


Consumer reviews


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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