Pamorelin LA 11.25mg Injection 1’s

INTRODUCTION

PAMORELIN LA 11.25MG INJECTION contains Triptorelin which belongs to the group of medicines called Gonadotropin-releasing hormone (GnRH) agonists. PAMORELIN LA 11.25MG INJECTION is used in men to treat prostate cancer and in women to reduce the size of uterine fibroids (non-cancerous tumours arising from the smooth muscle layer of the uterus) and to treat endometriosis (a condition in which the tissue that normally lines the uterus grows in other places).

PAMORELIN LA 11.25MG INJECTION can also be used in children to treat central precocious puberty (puberty that occurs before 8 years in girls and 10 years in boys).

PAMORELIN LA 11.25MG INJECTION should be used with caution in patients with high blood pressure, liver, kidney and heart diseaase, diabetes, benign tumour of pituitary gland or have pains in bones and difficulty passing urine. Consult your doctor before receiving it.

PAMORELIN LA 11.25MG INJECTION is not recommended for use in pregnant and breast-feeding women. PAMORELIN LA 11.25MG INJECTION should be used with caution in children (girls under 9 years of age and boys under 10 years of age) for the treatment of early puberty. Consult your doctor before receiving it.

The most common side effects of receiving PAMORELIN LA 11.25MG INJECTION are hot flushes, weakness, excessive sweating, back pain, pins and needles sensation in the legs, reduced libido and impotence, nausea, dry mouth etc. Contact your doctor if any of the symptoms worsen.

USES OF PAMORELIN LA 11.25MG INJECTION

PAMORELIN LA 11.25MG INJECTION is used

In men to treat prostate cancer
In women to reduce uterine fibroids and to treat endometriosis
In children to treat central precocious puberty
HOW PAMORELIN LA 11.25MG INJECTION WORKS

PAMORELIN LA 11.25MG INJECTION is similar to the gonadotropin releasing hormone which occurs naturally in your body. In men, PAMORELIN LA 11.25MG INJECTION lowers the levels of the hormone testosterone and helps to treat prostate cancer. In women, it reduces oestrogen levels, helps to reduce the size of uterine fibroids and treats endometriosis.

In children PAMORELIN LA 11.25MG INJECTION helps to supress gonadotropin (hormone) secretion in brain and helps to block pubertal development and also reduces the action of sex steroid hormones on bone maturation in order to restore normal long-term growth of the skeleton.

DIRECTIONS FOR USE

PAMORELIN LA 11.25MG INJECTION will be given to you only by a doctor or a nurse as an intramuscular injection (into a muscle) or subcutaneous injection (just under the skin). Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

Do not stop using PAMORELIN LA 11.25MG INJECTION unless your doctor advised you to stop. Otherwise, your symptoms are likely to return.

SIDE EFFECTS OF PAMORELIN LA 11.25MG INJECTION
COMMON
Hot flushes
Weakness
Excessive sweating
Pins and needles sensation in the legs
Reduced libido and impotence
Nausea, dry mouth, abdominal pain
Bruising, redness and swelling at injection site
Muscle and bone pain, back pain, pain in the arms and legs
Oedema (build-up of fluid in the body tissues)
Allergic reaction
Increase in weight
Dizziness, headache
Depression and mood changes
Pain, swelling and tenderness
Nervousness
Difficulty in sleeping
Breast disorder, breast pain
Ovarian hyperstimulation syndrome
Pain during or after sexual intercourse
Painful periods, vaginal bleeding
Pelvic pain
Dryness of the vagina
Acne, oily skin
UNCOMMON
Feeling your heartbeat
Ringing in the ears, vertigo
Blurred vision, dry eye
Bloating, flatulence, constipation, diarrhoea, vomiting
Severe shivering associated with sweating and a fever
Sleepiness
Increased weight loss
Change in appetite
Gout (severe pain and swelling in the joints usually in the big toe)
Diabetes
Muscle weakness
Feeling of irritability
Development of enlarged breasts in men,
Reduction in testicular size, pain in testicles
Difficulty in breathing
Hair loss
Waking up to pass urine, problems passing urine
Nosebleeds
Abnormal taste
Loss of sensations
Temporary loss of consciousness
Memory loss, lack of concentration,
Involuntary muscle movement
Anxiety, disorientation
Bleeding after sex
Prolapse
Irregular period, painful period and heavy period
Small cysts (swelling) on the ovaries which can cause pain, discharge from the vagina
Dry skin
Excessive bodily hair
Brittle nails
RARE
Red or purple discolorations on the skin, blisters
Abnormal sensation in the eye
Chest pain
Trouble standing
Flu-like symptoms, fever
Inflammation of the nose or throat
Osteoarthritis
Decreased activity
Having a feeling of elation
Breathlessness when lying flat

Stop receiving PAMORELIN LA 11.25MG INJECTION and contact your doctor immediately if you experience any of the following side effects:

Severe allergic reaction like angioedema or anaphylactic reaction (swallowing or breathing problems, dizziness, a rash, swelling of lips, face, throat or tongue)
Symptoms of brain hemorrhage (pituitary apoplexia) such as sudden headache, vomiting, problems with vision
HOW TO MANAGE SIDE EFFECTS

Headache:

Rest and relax. Drink plenty of fluids such as water or ORS (Oral Rehydrating Solution) and apply a pain-relieving balm on the head if necessary. Contact your doctor if your headache did not improve.

Nausea and vomiting:

Receive PAMORELIN LA 11.25MG INJECTION, with or just after a meal. Stick to simple meals. Avoid eating oily or spicy food. Contact your doctor if your nausea and vomiting did not improve.

Stomach pain:

Try to have smaller meals but take frequently. Keep a heat pad on your stomach. Do not self-treat and contact your doctor if the stomach pain did not improve.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operate any machines while you are feeling dizzy. Do not drink alcohol, as it can aggravate your dizziness. Contact your doctor if your dizziness did not improve.

Diarrhoea:

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Do not take any medicine on your own for treating diarrhoea. Contact your doctor if your diarrhoea did not improve.

Constipation:

Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals and drink plenty of fluids. Exercise more regularly and stay active. Contact your doctor if constipation persists.

Loss of appetite:

Eat when you are hungry. Eat smaller meals more often than usual. Eat a nutritious snack which is rich in calories and protein, such as dried fruit and nuts. Contact your doctor if your appetite did not improve.

Flatulence:

Eat smaller and frequent meals. Eat and drink slowly and exercise regularly. Contact your doctor if flatulence persists.

WARNING & PRECAUTIONS
PREGNANCY

PAMORELIN LA 11.25MG INJECTION is not recommended for use in pregnant women. Consult your doctor before receiving PAMORELIN LA 11.25MG INJECTION.

Use contraceptives method such as condom or diaphragm (cap) during treatment with PAMORELIN LA 11.25MG INJECTION and until menses resume.

BREASTFEEDING

PAMORELIN LA 11.25MG INJECTION is not recommended for use in breastfeeding women. Consult your doctor before receiving PAMORELIN LA 11.25MG INJECTION.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you have dizziness, tiredness, sleep disturbances or insomnia, blurry vision after receiving PAMORELIN LA 11.25MG INJECTION.

ALCOHOL

Inform your doctor if you drink excessive amounts of alcohol as it might cause thinning of bones.

KIDNEY

PAMORELIN LA 11.25MG INJECTION should be used with caution in patients with kidney disease. Consult your doctor before receiving PAMORELIN LA 11.25MG INJECTION.

LIVER

PAMORELIN LA 11.25MG INJECTION should be used with caution in patients with liver disease. Consult your doctor before receiving PAMORELIN LA 11.25MG INJECTION.

ALLERGY

Do not receive PAMORELIN LA 11.25MG INJECTION if you are allergic to Triptorelin or similar other GnRH agonists or any of the other ingredients of PAMORELIN LA 11.25MG INJECTION.

HEART DISEASE

PAMORELIN LA 11.25MG INJECTION should be used with caution in patients with high blood pressure, heart rhythm problems, heart attack and heart failure. Consult your doctor before receiving PAMORELIN LA 11.25MG INJECTION.

OTHERS

Before receiving PAMORELIN LA 11.25MG INJECTION, inform your doctor if you:

Or any of your family member have thinning of the bones
Smoke heavily
Have urinary obstruction or compressed nerves in your backbone due to spreading of your prostate cancer
Have surgical removal of testicles
Have diabetes (high blood sugar)
Have benign tumour of pituitary gland
Have pains in your bones or difficulty passing urine
Have back pain, weakness, numbness or tingling in your legs
Have progressive brain tumour (in children)
Have stroke, mini stroke
Have a low level of potassium, calcium or magnesium in your blood
Have a mental illness
Have fits

Use in pediatrics:

PAMORELIN LA 11.25MG INJECTION should be used with caution in children (girls under 9 years of age and boys under 10 years of age) for the treatment of early puberty. Consult your doctor before receiving PAMORELIN LA 11.25MG INJECTION.

PAMORELIN LA 11.25MG INJECTION is not recommended for use in adolescents and young girls (under 18 years of age) for the treatment of endometriosis as it might cause thinning of bone. Consult your doctor before receiving it.

INTERACTIONS

A. Drug – Drug interactions:

Before receiving PAMORELIN LA 11.25MG INJECTION, inform your doctor if you are taking any of the following medicine:

Medicines used to treat heart rhythm problems (Ex. quinidine, procainamide, amiodarone, sotalol)
Methadone (used to relieve pain and in drug dependence detoxification)
Moxifloxacin (used to treat bacterial infections)
Medicines used to treat serious mental illnesses (Ex. olanzapine, risperidone, haloperidol)
Medicines that increase the level of a hormone called prolactin (Ex. clomipramine)
Medicines used to delay blood clotting (Ex. heparin, warfarin)
Medicines used to treat fits (Ex. lamotrigine, carbamazepine)
Medicines used to treat inflammatory conditions (Ex. hydrocortisone, prednisolone)
Reserpine, methyldopa (used to treat high blood pressure)
Metoclopramide (used to treat nausea and vomiting)
Bupropion and selective serotonin reuptake inhibitors Ex. fluoxetine, sertraline and paroxetine (medicines used to treat depression)

Overdosage:

PAMORELIN LA 11.25MG INJECTION will be administered to you only by a doctor or a nurse in a hospital and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms after receiving PAMORELIN LA 11.25MG INJECTION.

SYNOPSIS
Drug :   Triptorelin
Pharmacological Category :   Gonadotropin-releasing hormone (GnRH) agonists
Therapeutic Indication :   Prostate cancer (men), Endometriosis, uterine fibroids (women), Central precocious puberty (children)
Dosage Forms :   Injection
MORE INFORMATION
Keep PAMORELIN LA 11.25MG INJECTION out of reach of children
Store PAMORELIN LA 11.25MG INJECTION below 25°C
FAQs ABOUT PAMORELIN LA 11.25MG INJECTION

Will PAMORELIN LA 11.25MG INJECTION lower my hormones immediately?

No. When you first start treatment with PAMORELIN LA 11.25MG INJECTION, it increases the level of your hormones for a short time, which may make you feel worse initially. After a short time of treatment with PAMORELIN LA 11.25MG INJECTION, your hormone levels will drop and your symptoms will improve.

Can PAMORELIN LA 11.25MG INJECTION affect my periods?

PAMORELIN LA 11.25MG INJECTION may cause some vaginal bleeding in the first month of treatment, after which your periods usually stop. Tell your doctor if you have bleeding after the first month of treatment. They resume approximately 5 months after the last dose of PAMORELIN LA 11.25MG INJECTION. In girls, menstrual bleeding will start on average one year after stopping treatment for early puberty.

Can I get pregnant while using PAMORELIN LA 11.25MG INJECTION?

PAMORELIN LA 11.25MG INJECTION is not recommended for use in pregnancy. You must use some form of contraception other than the ‘pill’ while you are having treatment and until you start your next period. Discuss with your doctor regarding use of barrier methods like a condom or diaphragm while receiving PAMORELIN LA 11.25MG INJECTION.

Can I stop receiving PAMORELIN LA 11.25MG INJECTION?

Receive PAMORELIN LA 11.25MG INJECTION as advised by your doctor. Do not stop using PAMORELIN LA 11.25MG INJECTION unless your doctor advised you to stop. Otherwise, your symptoms are likely to return.

Does PAMORELIN LA 11.25MG INJECTION cause weight gain?

PAMORELIN LA 11.25MG INJECTION may cause weight gain- especially in the waist. Eat a healthy diet and getting regular exercise can help you control your weight. Contact your doctor if any of the symptoms worsen.

REFERENCES

1. Barbara G. Wells, Joseph T. DiPiro, Terry L. Shwinghammer, Cecily V. DiPiro. Prostate cancer. Pharmacotherapy Handbook. Ninth edition. 2015. Page- 663.

2. Bethesda (MD).  Triptorelin. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. National Institute of Diabetes and Digestive and Kidney Diseases. March 2022. [Accessed on 11th June 2022] https://www.ncbi.nlm.nih.gov/books/NBK548756/

3. Chiocca E, Dati E, Baroncelli GI, Cassio A, Wasniewska M, Galluzzi F, Einaudi S, Cappa M, Russo G, Bertelloni S. Central precocious puberty: treatment with triptorelin 11.25 mg. NIH National Library of Medicine, National Center for Biotechnology Information. PubMed Central. May 2012. [Accessed on 11th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3356708/

4. Jean- Claude Carel. Treatment of precocious puberty by GnRH agonists. NIH National Library of Medicine, National Center for Biotechnology Information. PubMed.gov. October 2005. [Accessed on 11th June 2022] https://pubmed.ncbi.nlm.nih.gov/16302717/

5. Ipsen. A Study to Describe the Efficacy of Diphereline Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months (DIE-NIS). NIH U.S. National Library of Medicine ClinicalTrials.gov. December 2018. [Accessed on 11th June 2022] https://clinicaltrials.gov/ct2/show/NCT01942369

6. Ipsen Pharma Biotech. Electronic Medicines Compendium (EMC). [Revised in May 2022] [Accessed on 11th June 2022] https://www.medicines.org.uk/emc/files/pil.780.pdf

7. Ferring GmbH. Electronic Medicines Compendium (EMC). [Revised in October 2019] [Accessed on 11th June 2022] https://www.medicines.org.uk/emc/files/pil.2229.pdf

8. Ferring GmbH. Health Products Regulatory Authority (HPRA). [Revised in October 2019] [Accessed on 11th June 2022] http://www.hpra.ie/img/uploaded/swedocuments/7143c597-b1e4-450f-9704-fc5131582ad9.pdf

USEFUL DIAGNOSTIC TESTS
Digital rectal exam (DRE)
Prostate-specific antigen (PSA) test
Laparoscopy
GnRH stimulation test
Net Qty
1 N
Ingredient
TRIPTORELIN 11.25MG
Hsn Code
30049099
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