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Assurans Injection 12.5ml

Patanjali Pharma (15.9 km)

₹2396

INTRODUCTION ASSURANS contains Sildenafil which belongs to the group of medicines called Phosphodiesterase type 5 (PDE 5) inhibitors. It is used in adults to treat pulmonary arterial hypertension (PAH). PAH can be defined as an increased blood pressure in the blood vessels that supplies the lu...

INTRODUCTION

ASSURANS contains Sildenafil which belongs to the group of medicines called Phosphodiesterase type 5 (PDE 5) inhibitors. It is used in adults to treat pulmonary arterial hypertension (PAH). PAH can be defined as an increased blood pressure in the blood vessels that supplies the lungs. It can be caused due to narrowing of blood vessels (arteries) supplying the heart and the lungs. Symptoms of PAH might include shortness of breath, tiredness, weakness, and feeling faint.

Sildenafil reduces blood pressure within the lungs by relaxing the blood vessels supplying the lungs. This enhances blood flow and oxygen supply to the lungs which ultimately reduces pressure within the lungs and improves its functions. ASSURANS should be used in patients who temporarily cannot take any medicines orally to treat pulmonary arterial hypertension.

Before receiving ASSURANS inform your doctor if you have any liver, kidney, or heart problems. It should be used with caution in patients with eye problems, stomach problems, anemia, or penile deformity. Avoid consuming grapefruit juice just before receiving ASSURANS, as it may increase the risk of side effects.

ASSURANS should be used in pregnant or breastfeeding women only if it is considered necessary by the physician. Women of childbearing potential should use suitable contraceptive method to avoid pregnancy while undergoing therapy with ASSURANS. It is also not recommended for use in children and adolescents (below 18 years).

The most common side effects of ASSURANS are headache, muscle pain or stiffness, dizziness, blurred vision, or flushing. Consult your doctor if any of the side effect troubles you. Also inform your doctor if you experience any painful or prolonged erections after receiving ASSURANS.

USES OF ASSURANS

  • Treats pulmonary arterial hypertension in adults

HOW ASSURANS WORKS

ASSURANS reduces blood pressure within the lungs, where sildenafil acts by blocking the effects of certain enzymes (PDE5) which limits blood flow to the lungs. As a result, it causes widening of blood vessels (arteries) supplying the lungs, improves blood supply to the lungs and enhances pulmonary functions.

DIRECTIONS FOR USE

ASSURANS will be given to you only by a doctor or a nurse into the vein (intravenously). Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF ASSURANS

COMMON

  • flushing, fever
  • headache, shaking and migraine
  • effects on nose (nosebleed, stuffy nose, runny nose and inflammation of sinuses)
  • effects on vision (includes light sensitivity, blurred vision, color tinge to vision,  visual disturbance, eye irritation, red eyes)
  • nausea
  • low blood pressure
  • pain in legs, arms, back and muscles
  • night sweats
  • infection under skin and redness
  • decreased number of RBCs
  • flu-like symptoms
  • anxiety
  • difficulty in sleeping
  • retention of fluid
  • reduced sense of touch or pricking of pins and needles sensation
  • vertigo (spinning sensation)
  • dry mouth
  • digestive system issues (stomach pain, outward swelling of the stomach, indigestion, heartburn and piles)
  • cough
  • diarrhea

UNCOMMON

  • eye problems (reduced sharpness of vision, double vision and abnormal sensation in the eye)
  • breast enlargement in men
  • presence of blood in semen/ urine
  • penile bleeding

RARE

Consult your doctor immediately if you experience any of the following side effects after receiving ASSURANS:

  • prolonged or painful erection
  • decreased or loss of vision in one or both eyes

HOW TO MANAGE SIDE EFFECTS

Headache:

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

WARNING & PRECAUTIONS

PREGNANCY

ASSURANS is generally not recommended for use in pregnant unless considered necessary by the physician. Therefore, consult your doctor before receiving it. Women of child-bearing potential should use proper contraceptive method to avoid pregnancy while undergoing therapy with ASSURANS.

BREASTFEEDING

ASSURANS should be used with caution for use in breastfeeding women. Therefore, consult your doctor before receiving it.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you experience dizziness or blurred vision after receiving ASSURANS.

ALCOHOL

Avoid consumption of alcohol while receiving ASSURANS as it may reduce the effectiveness of ASSURANS.

KIDNEY

ASSURANS should be used with caution in patients with kidney problems. Therefore, consult your doctor before receiving it.

LIVER

ASSURANS is not recommended for use in patients with severe liver diseases. It should be used with caution in patients with other minor liver problems. Therefore, consult your doctor before receiving it.

ALLERGY

Do not receive ASSURANS if you are allergic to Sildenafil.

LUNGS

ASSURANS should be used with caution in patients with pulmonary hypertension caused due to narrowing or blockade of veins (instead of  arteries). Consult your doctor before receiving it.

HEART DISEASE

ASSURANS is not recommended for use in patients with severe heart diseases (such as any recent heart attack or stroke, or severe low blood pressure). It should be used with caution in patients with other heart problems (such as problems in heart chambers or valves, low blood pressure at rest). Therefore, consult your doctor before receiving it.

OTHERS

ASSURANS is not recommended for use if you:

  • previously had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION; a type of nerve damage caused due to lack of blood and oxygen supply to the eye)

Before receiving ASSURANS inform your doctor if you:

  • have sickle cell anaemia (an inherited blood disorder characterized by low RBC count)
  • have any type of rare inherited eye diseases (such as retinitis pigmentosa)
  • have cancers of blood (leukaemia) or bone marrow (multiple myeloma)
  • have penile deformation
  • have Peyronie’s disease (development of fibrous scar tissue that results in painful erection)
  • have stomach ulcer or bleeding disorder such as haemophilia
  • have nosebleeds
  • have dehydration due to diarrhoea, fever, or less intake of fluids or increased sweating

Use in pediatrics:

ASSURANS is not recommended for children and adolescents (under the age of 18 years). Therefore, consult your doctor before receiving.

Use in geriatrics:

ASSURANS should be used with caution in elderly patients. Therefore, consult your doctor before receiving.

INTERACTIONS

A. Drug-Drug interactions:

Before receiving ASSURANS, inform your doctor if you are taking any of the following:

  • nitrates or amyl nitrites (used for reliving chest pains) Ex. nitroglycerin and isosorbide dinitrite
  • other medicines used to treat PAH (Ex. riociguat, bosentan or iloprost)
  • medicines used to treat prostate problems or blood pressure such as alpha-blocker (Ex. silodosin, doxazosin)
  • ketoconazole or itraconazole (used to treat fungal infections)
  • St. John’s wort or nefazodone (used to treat depression)
  • antibiotics (used to treat bacterial infections) Ex. erythromycin, clarithromycin and telithromycin
  • rifampicin (used in treatment of tuberculosis)
  • saquinavir and ritonavir (used to treat HIV infections)
  • medicines used for blood thinning (Ex. warfarin)
  • medicines used to treat epilepsy (Ex. carbamazepine, phenytoin, and phenobarbital)
  • medicines used to treat erectile dysfunction (Ex. tadalafil)

B. Drug-Food Interactions:

Avoid drinking grapefruit juice while receiving ASSURANS as it may increase the risk of side effects.

Overdosage:

ASSURANS will be given to you only by a doctor or nurse in a hospital, and so it is unlikely to receive an overdose. However, if you experience any unusual symptoms contact your doctor immediately.

SYNOPSIS

Drug : Sildenafil
Pharmacological Category : Phosphodiesterase type 5 inhibitors
Therapeutic Indication : Pulmonary Arterial Hypertension
Dosage Forms : Tablet, Capsule, Oral Disintegrating Strips, Oral Jelly, Injection, Effervescent Tablet, Spray

MORE INFORMATION

  • Keep ASSURANS out of reach of children
  • Store ASSURANS at room temperature

FAQs ABOUT ASSURANS

What are the uses of ASSURANS?

ASSURANS is used to treat pulmonary arterial hypertension (PAH) in adults. It reduces blood pressure within the lungs by relaxing the blood vessels supplying the lungs.

What does ASSURANS do?

ASSURANS reduces blood pressure within the lungs, where sildenafil acts by blocking the effects of certain enzymes (PDE5) which limits blood flow to the lungs. As a result, it causes widening of blood vessels (arteries) supplying the lungs, improves blood supply to the lungs and enhances pulmonary functions.

How to take ASSURANS?

ASSURANS is not meant for self-administration. It will be given to you only by a doctor or a nurse into the vein (intravenously). Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.

Can elderly men receive ASSURANS ?

Yes. ASSURANS should be used with caution in elderly patients, especially if they have any pre-existing heart conditions and taking medicines for it. Consult your doctor before receiving.

Can ASSURANS be used in women?

Yes. ASSURANS can be used in women for treating pulmonary arterial hypertension. However, it should be used in pregnant or breastfeeding women only if considered necessary by the physician. Therefore, consult your doctor before receiving it. Women of child-bearing potential should use proper contraceptive method to avoid pregnancy while undergoing therapy with ASSURANS.

Can ASSURANS treat erectile dysfunction?

No. ASSURANS is not meant for treating erecrtile dysfunction. It is used for treating pulmonary arterial hypertension in adults. If you wish to treat erectile dysfunction, consult your doctor for advice. Your doctor would either prescribe a higher dose of sildenafil or suggest an alternative therapy based on your medical condition.

What are the side effects of ASSURANS?

The most common side effects of ASSURANS are headache, dizziness, blurred vision, or flushing. Consult your doctor if any of the side effect troubles you. Also inform your doctor if you experience any painful or prolonged erections after receiving ASSURANS.

Can ASSURANS affect sexual performance?

No. ASSURANS is used to reduce increased blood pressure in the lungs. It may have influence on erection but cannot improve sexual performance.

Can ASSURANS cause painful erections?

Yes. ASSURANS may cause painful and prolonged erections. Inform your doctor if you experience any such effects.

What medicines should I avoid while taking ASSURANS?

Before receiving ASSURANS, inform your doctor about all the medicines that you use to treat your current illnesses. Avoid concomittant use of similar medicines which can relaxes your blood pressure such as nitrates (Ex. nitroglycerin). It is also important to inform your doctor about the use of antibiotics (Ex. erythromycin, clarithromycin, telithromycin, rifampicin), antivirals (Ex. saquinavir and ritonavir) and antiepiletic drugs (Ex. carbamazepine, phenytoin) before undergoing treatment with ASSURANS.

Can I consume alcohol before receiving ASSURANS?

No. Consumption of alcohol before receiving ASSURANS may reduce the effectiveness of this medicine. Avoid alcohol to achieve maximum benefits of ASSURANS.

REFERENCES

1. K.D. Tripathi. Androgens and Drugs for Erectile Dysfunction. Essentials of medical pharmacology. Seventh edition. 2013. Page – 303-304.

2. Sukhdeep Bhogal, Ola Khraisha, Mohammad Al Madani, Jennifer Treece, Steven Baumrucker and Timir K Paul. Sildenafil for Pulmonary Arterial Hypertension. NIH National Library of Medicine, National center for biotechnology information. Jul/Aug 2019. [Accessed on 6th May 2022] https://pubmed.ncbi.nlm.nih.gov/30946047/

3. Yen-Chun Lai, Karin C. Potoka, Hunter C. Champion, Ana L. Mora and Mark T. Gladwin. Pulmonary Arterial Hypertension: The Clinical Syndrome. June 2014. [Accessed on 6th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4096686/pdf/nihms598840.pdf

4. Pfizer Ltd. Electronic Medicines Compendium (EMC). [Revised in January 2021] [Accessed on 18th April 2022] https://www.medicines.org.uk/emc/files/pil.458.pdfc

5. Upjohn UK Ltd. Electronic Medicines Compendium (EMC). [Revised in January 2021] [Accessed on 18th April 2022] https://www.medicines.org.uk/emc/product/458/smpc#gref

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