Valif Oral Jelly

Ajanta Pharmaceutical Limited, India

The active ingredient is vardenafil hydrochloride trihydrate. Each Valif Oral Jelly sachet contains 20 mg of vardenafil.

Valif Jelly (Vardenafil Oral Jelly) is used to treat erectile dysfunction in adult men. Erectile dysfunction refers to the inability to achieve or maintain a penile erection sufficient for successful sexual performance. Valif Jelly (Vardenafil Oral Jelly) starts working approximately 30 minutes after ingestion, and its effects last longer than sildenafil, which lasts about 5 hours.

The recommended dosage for Valif 20 mg jelly is one oral dose per day, with or without food. This means at least 24 hours should pass before the next dose.

The recommended starting dose of vardenafil is 5 mg for patients with moderate hepatic impairment (Child-Pugh B). The maximum dose for patients with moderate impairment should not exceed 10 mg. Therefore, vardenafil 20mg jelly is not recommended for such patients. The same applies if patients are taking potent and moderate inhibitors of CYP3A4; in such cases, the dose should be reduced.

This medicine is not recommended for patients on dialysis as vardenafil is not a medicine tested in this patient group.

Valif Oral Jelly can be taken approximately 15 minutes before sexual activity. The sachet is opened, and its contents are ingested. One Valif Jelly sachet is for single use only. Take this medication under the supervision of a doctor.

It can be taken with or without food. The full effect of one dose (one sachet of five grams) can last approximately 3-4 hours, and in some cases, the effects can last up to 24 hours. Do not take more than one dose per day (at least 24 hours should pass between doses).

It is essential to take a maximum of 1 sachet of oral jelly per day. It is also not recommended to take it daily.

Store Vardenafil Oral Jelly at controlled room temperature (between 15°C and 30°C). Keep it in an airtight, dry, and dark place. Protect it from strong sunlight. Keep it out of the reach of children.

It is not recommended for those who are hypersensitive (allergic) to vardenafil or any other component of this medicine.

The use of Valif Jelly in combination with nitrates (either frequently or occasionally) and nitric oxide donors is not recommended. Since PDE5 inhibitors have an effect on the nitric oxide/cGMP pathway, PDE5 inhibitors like Valif 20mg Oral Jelly may enhance the hypotensive effects caused by nitrates. The optimal time frame for dosing Valif Jelly for the safety of administering nitrates and nitric oxide donors has not yet been established.

Before starting treatment for erectile dysfunction, the problem of erection and potential causes for it should be determined through physical examination and medical history. Before using pharmacological treatment, patients’ cardiovascular condition should be considered, as sexual activity is associated with risk for the heart. Vardenafil is a vasodilator, causing mild and transient decreases in blood pressure. Patients with a condition called left ventricular outflow obstruction, such as aortic hypertrophic subaortic stenosis, may become sensitive to the action of vasodilators like PDE5 inhibitors.

Valif 20 mg jelly may increase the blood pressure-lowering effects of antihypertensive drugs. Other warnings and precautions for the use of generic vardenafil oral jelly (Valif 20 mg jelly) include:

Cardiovascular effects: Patients with heart conditions should not take Valif Oral Jelly if sexual activity is not recommended due to their cardiovascular status.

Risk of priapism: If an erection lasts longer than four minutes, the individual should seek medical assistance immediately.

Effects on the eyes: Effects on the eyes are a significant concern, and patients should discontinue using the medication and seek medical assistance if they experience sudden vision loss in one or both eyes, which may indicate non-arteritic anterior ischemic optic neuropathy (NAION). Valif Oral Jelly should be used with caution and only if the benefits outweigh the potential risks in patients with a history of NAION. Patients with “crowded disk” may be at a higher risk of developing NAION.

Sudden hearing loss: Patients should discontinue using Valif Oral Jelly and seek medical assistance if they experience sudden hearing loss or decrease.

Alpha-blockers: Be cautious when co-administering PDE5 inhibitors and beta-blockers. In some patients, concurrent use of both drug classes can significantly lower blood pressure, leading to hypotensive symptoms (e.g., fainting).

QT interval prolongation: Individuals with congenital QT syndrome or those taking class IA and III antiarrhythmics should not use Valif Oral Jelly (vardenafil jelly).

In a co-administration with alcohol in a four-hour observation period in healthy volunteers, vardenafil did not increase the hypotensive effects of alcohol (0.5 g/kg body weight; approximately 40 ml of pure alcohol in a person weighing 70 kg). Plasma levels of alcohol and vardenafil were not altered during concurrent use.

Studies on the effects on the ability to drive or operate machinery during treatment with vardenafil (Valif 20 mg oral jelly) have been conducted. Since dizziness and blurred vision have been observed in clinical trials with vardenafil tablets, patients should be attentive to their reactions while using vardenafil before driving or operating machinery.

The most common adverse effects reported by at least 2% of patients receiving treatment with vardenafil (Valif Oral Jelly) include headache, flushing, and dyspepsia, nasal congestion, sinusitis, flu-like symptoms, dizziness, increased creatine kinase levels, nausea, and back pain.

The following section lists less frequent but minor side effects with an incidence of less than 2%, identified during the development of vardenafil tablets and vardenafil orally disintegrating tablets. The list is not exhaustive for rare and minor side effects, as well as events that may occur without treatment and events not associated with the drug:

General: angioedema

 and allergic edema, malaise, discomfort, allergic reactions, and chest discomfort

Hearing: tinnitus, dizziness

Cardiovascular: palpitations, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmia, hypotension

Gastrointestinal: the most common symptoms are nausea, abdominal and stomach discomfort, dry mouth, gastroesophageal reflux disease, diarrhea, gastritis, vomiting, increased transaminases

Musculoskeletal: increased creatine phosphokinase (CPK) in muscles and cramps, muscle cramps

Neurological: dysesthesia and paresthesia, drowsiness, sleep disturbances, amnesia, syncope, seizures

Respiratory problems: nasal congestion

Appendages and skin, including rash, erythema

Ocular: impaired vision, eye redness, color distortion, eye pain and irritation, photophobia, elevated intraocular pressure, and conjunctivitis

Urogenital: increased erection and increased priapism

Signs of overdose with vardenafil tablets are not well known but are believed to include back pain, dizziness, irregular heartbeat, and abnormal vision.

The highest dose of vardenafil (Valif Oral Jelly) for which data based on humans are available is a single dose of 120 mg, which was administered to healthy male subjects. Most subjects experienced irreversible back pain or myalgia and/or “abnormal vision.” A single dose of vardenafil up to 80 mg and multiple doses up to 40 mg of vardenafil per day for four weeks were not tolerated and did not cause serious adverse effects. Instances of severe back pain were recorded with the administration of 40 mg of vardenafil twice a day. No neurotoxic or myotoxic effects were observed.