Primolut N

Primolut N

Table of Contents

  1. What is Primolut N?
  2. Constituents
  3. Indications
  4. How does Primolut N work?
  5. How to Take Primolut N?
  6. Common Dosage for Primolut N?
  7. When to Avoid Primolut N?
  8. Side-effects of Primolut N?
  9. Effects on organs?
  10. Reported Allergic Reactions?
  11. Effect on menstrual cycle?
  12. Drug Interactions To Be Careful About
  13. Food interactions
  14. Interactions with laboratory procedures
  15. Shows Effects / Results In and how long does the effect stay:
  16. Is Primolut N Addictive?
  17. Can I have Primolut N with alcohol?
  18. Can I have Primolut N When Pregnant?
  19. Can I have Primolut N while feeding a baby?
  20. Can I drive after taking Primolut N?
  21. Effect of an overdose of Primolut N?
  22. Effect of using expired Primolut N?
  23. Effect of missing a dose of Primolut N?
  24. Storage requirements
  25. Substitutes for Primolut N
  26. Expert comments

What is Primolut N?

Primolut N is a branded medication used majorly as a contraceptive and also to treat several other health conditions in women. Let’s explore more details about this medication in this article written and reviewed by our medical experts.

According to the statistics by National Center for Health Statistics (NCHS), approximately above 65% of the women in United States of America tend to use contraception methods and among this number above 12.6% are expected to use the pill control method. 3

Type of drug

Primolut N belongs to progestin medicine. Progestin is a synthetic form of a naturally occurring human hormone called progesterone, a female sex hormone. Thishormone plays a major role in women’s body and shows its effect on the menstrual cycle and pregnancy.

Progestin is used in the preparation of many kinds of medicine used as birth control methods such as pills, vaginal rings, skin patches.

Progestin is used individually in some medications such as birth control implants and the hormonal intrauterine devices (IUD) and also as a combination medicine with estrogen.

Use in brief

Primolut N is prescribed mainly in the treatment of birth control and hormone therapy in polycystic ovarian syndrome, menopause, secondary amenorrhea, endometriosis, abnormal uterine bleeding due to hormonal imbalance without any underlying pathology such as sub mucous fibroid or uterine cancer.

Constituents

Primolut N contains Norethisterone as an active ingredient. Norethisterone is also called as Norethindrone.

Manufactured by – Zydus Cadila Pharmaceuticals Ltd.

Primolut N brand is available with Norethisterone as an active ingredient in the countries mentioned below.

  • Australia
  • Finland
  • Iceland
  • India
  • Indonesia
  • Ireland
  • Kuwait
  • Netherlands
  • New Zealand
  • Norway
  • Philippines
  • South Africa
  • Thailand
  • Turkey
  • United Kingdom
  • Vietnam

Aygestin and Errin are the alternative brands for Primolut N available in the United States with Norethindrone acetate as a key ingredient. Aygestin as 5 mg oral tablets, Errin as 0.35mg oral tablets.

Indications

Prescribed to treat gynaecological conditions in women such as –

  • Birth control pills to prevent pregnancy
  • Conditions caused by hormonal imbalance like menstrual disorders, endometriosis and abnormal vaginal bleeding in some patients.
  • Premenstrual tension (PMT) or premenstrual syndrome (PMS)
  • Irregular periods
  • Heavy periods
  • Painful periods

How does Primolut N work?

This medicine basically belongs to Progestin type of drugs and works by –

  • Thickening of the mucus in the cervix which makes it difficult for the sperms to swim through and reach the uterus to fertilize an egg.
  • Stopping the ovulation, but it is not so accurate there is a chance of ovulation in nearly 40% of the women who use these Progestin pills.
  • Thins the lining of the uterus.

When to use

Follow the instructions as mentioned in the prescription. In general, it is advised to take after your dinner or any snack before bed to avoid nausea. Depending on your medical condition your doctor may prescribe this medicine to take twice or thrice a day. Follow the instructions given by your doctor for accurate results.

How to use

Do not crush or chew the tablet; swallow it as a whole with water.

Common Dosage for Primolut N

The dosage depends on the condition you are being treated for and is decided by the doctor. Follow the instruction by your doctor. Do not miss a dose or take an excess dose. Consult your doctor immediately in case of overdosage.

It is available as 5mg oral tablets. The general dosage of the medication in most of the cases would be twice to thrice a day.

When to Avoid Primolut N?

Primolut N is not advised to use in some health conditions such as:

  • Allergic to the ingredients of the medicine or similar medications. Allergic reactions may include
    • Breathing difficulty or shortness in breathing
    •  Swelling of facial organs like facial muscles, lips, and tongue
    • Skin reactions like rashes, itching, and hives
  • Not advised to use in pregnancy, or expecting a pregnancy
  • While Breast feeding
  • Not advised to use in case of clotting disorders like the below mentioned. Besides, there is a chance of a higher risk of clotting disorders by using hormonal medicine such as Primolut N.
    • Deep vein thrombosis (DVT) – in the blood vessels of the legs
    • Pulmonary embolism – in the blood vessels of the lungs
    • Heart attack
    • Brain stroke
    • Not advised in case of frequent smokers due to the high risk of blood clots
  • Primolut N is not for women who are immobilized due to major trauma and major surgeries as it causes Venous Thromboembolism.
  •  Postmenopausal women. Concomitant therapy of Primolut N along with estrogen to treat postmenopausal women is contraindicated.
  • Liver diseases
  • Women with Breast Cancer
  • Vaginal bleeding in undiagnosed cases.

Primolut N Side-effects

Primolut N may possibly show some side effects in some patients. It is advised to consult your doctor if any of such side effects are noticed and if they are prolonged. Below mentioned are some possible side effects by Primolut N.

  • If you experience a headache for the first time after taking this medication.
  • If you experience very bad headaches during the usage of this medicine compared to your previous experience
  • If you notice any sudden changes in eyesight or hearing or speech
  • If you experience sudden changes in senses like taste, smell, and touch
  • Some commonly possible side effects are –
    • Nausea
    • Headache/migraine
    • Dizziness
    • Fatigue
    • Depression
    • Acne
    • Tenderness in the breasts
    • Sudden weight gain       
    • Irregular menstrual cycles
  • Some side effects are rare but you should consult your doctor immediately if you notice them, such as
    • Difficulty in vision
    • Difficulty in breathing
    • Abnormal growth of facial hair, or on body organs where the hair growth is minimal or negligible. This condition is called as Hirsutism
    • Voice changes in some women (very rare condition if used in excessive doses)
    • Yellowing of eyes (white area) and skin
    • Acute pain in the chest
    • Sudden weakness or numbness in the body particularly on one side of the body.
    • A decrease in sex drive
    • Fluid retention
    • Vaginal yeast infections
    • Enlargement of benign tumors of the uterus.

Effects on organs

It possibly shows some adverse effects on organs particularly if used in excess dose.

  • Blood clots in legs called deep vein thrombosis (DVT)
  • Blood clots in lungs, heart or even brain
  • May show an adverse effect on the liver in the case of patients suffering from liver diseases.

Reported Allergic Reactions?

No major allergic reactions are noticed in the case of Primolut N if used in the normal prescribed dosage. It is advised to consult your doctor if you notice any abnormal allergic reaction like the above-mentioned side effects.

Effect on menstrual cycle

Primolut N is known to show effects on menstrual cycle since it is hormonal medicine and intended to do so. It depends on the purpose it is prescribed to use depending on your health condition. Consult your doctor for a proper understanding of the effect on menstrual cycle as it depends on various factors like the problem you are getting the treatment and your general health condition.

Drug Interactions to Be Careful About

Primolut N may possibly show drug interaction with some other medication if they are used together. It is advised to share the medication details that you might be using any with your doctor before he prescribes this medicine to you.

Primolut N has the possibility of showing drug interaction if used along with the below-mentioned list of medicine.

  • Lamotrigine
  • Cetirizine
  • Montelukast
  • Carbamazepine
  • Mycophenolate Mofetil
  • Phenytoin
  • Tranexamic Acid
  • Phenobarbital
  • Griseofulvin
  • Insulin
  • Aminophylline
  • Clarithromycin
  • Divalproex

Food interactions

There is no major food interactions noticed to be taken care of while using this medicine. Follow the guidelines mentioned in the prescription as a safety precaution.

Interactions with laboratory procedures

This medicine can show an effect on laboratory test results in case of thyroid hormonal test and may alter the results. Let your doctor and lab technician be aware if you are using this medication while undergoing the thyroid test.

Shows Effects / Results in and how long does the effect stay:

This medicine is used as a course but not for single-time use, hence the effect of the medicine and results vary depending on the condition treated for and general health of the patient.

The typical onset of action the medication to reach peak plasma concentration is approximately 1 to 3 hours. The half-life of elimination from the body is about 5 to 12 hours. This medicine is mainly metabolized in the liver and excreted through urine and faeces.

Is Primolut N Addictive?

No drug addiction is noticed in case of Primolut N.

Can I have Primolut N with alcohol?

This medication is not known to show any adverse effects if consumed along with alcohol and there apparent risk involved. But as a general health concern, one should limit the consumption of alcohol considering various health factors.

Can I have Primolut N When Pregnant?

It comes under Pregnancy Category X: Contraindicated in pregnant women as there is an increased risk of birth defects in babies the pregnant women take this medication in the first trimester.

Can I have Primolut N while feeding a baby?

In general, the usage of Primolut N may result in decreased lactation (production of milk). Depending on your condition, follow the instruction provided by your doctor.

Can I drive after taking Primolut N?

Primolut N is not known to show an effect on driving ability and alertness. If you are feeling dizzy as a side effect, then is it not advised to do activities like driving in such condition and advised to consult your doctor.

Effect of overdose Primolut N

No adverse effects are noted as a result of an overdose. But as a general guideline, it is always safe to stick to the dosage mentioned as per your prescription. 

Effect of using expired Primolut N?

It is advised not to use any medicine that is expired to avoid any adverse effects. Consult your doctor immediately if any adverse effects are noticed by taking any expired medicine. It is advised to check the label while purchasing the medicine to verify the expiry date to be safe. The medication may not work as intended if it expired.

Effect of missing a dose of Primolut N

No major adverse effects are noticed if a certain dosage is missed. But it is advised to use other alternative options like the use of condoms in case of usage for pregnancy prevention.

Storage requirements

It is advised to store the medication away from direct sunlight and to keep at room temperature. Keep the medication away from the reach of the children and pets.

Substitutes for Primolut N

Your doctor may prescribe any of the substitute brands of the medication mentioned below as the key constituents of these brands of medicine is the same as Primolut N.

  • Aygestin
  • Errin
  • Camila
  • Heather
  • Micronor
  • Loestrin
  • Microgestin
  • Ortho-Novum
  • Modicon
  • Norinyl
  • Activelle
  • Estalis
  • Kliogest
  • Novofem
  • Trisequens

Expert comments

All these above medicines come under synthetic hormones called Progestins. These are different from Bio-identical progesterone derived from plants. Bioidentical progesterone is available with brand names- Prometrium, Crinone, etc. Bio-identical progesterone is used for the prevention of endometrial hyperplasia.

Reference:

  1. https://www.mydr.com.au/medicines/primolut-n-tablets
  2. https://www.medicines.org.uk/emc/product/1494/smpc
  3. https://www.cdc.gov/nchs/products/databriefs/db327.htm

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