Sintaser Side effects

• Side effects of Sintaser in details
• Sintaser contraindications
• Sintaser reviews

What are the possible side effects of Sintaser?

Get emergency medical help if you have any signs of an allergic reaction to Sintaser: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• slow or uneven heartbeats;

• a light-headed feeling, like you might pass out;

• wheezing or trouble breathing;

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• sudden weakness, vision problems, or loss of coordination;

• cold feeling in your hands and feet;

• depression, confusion, hallucinations;

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• low blood sugar - headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;

• low blood sugar in a baby - pale skin, blue or purple skin, sweating, fussiness, crying, not wanting to eat, feeling cold, drowsiness, weak or shallow breathing (breathing may stop for short periods), seizure (convulsions), or loss of consciousness; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Sintaser side effects may include:

• nausea, vomiting, diarrhea, constipation, stomach cramps;

• decreased sex drive, impotence, or difficulty having an orgasm;

• sleep problems (insomnia); or

• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Sintaser in details

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

• Hypoglycemia and related events, like hypoglycemic seizure.
• Bronchospasm.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in clinical practice.

Clinical Trials Experience with Sintaser in Infants with proliferating infantile hemangioma

In clinical trials for proliferating infantile hemangioma, the most frequently reported adverse reactions ( > 10%) in infants treated with Sintaser were sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhea, and vomiting. Adverse reactions led to treatment discontinuation in fewer than 2% of treated patients.

Overall, 479 patients in the pooled safety population were exposed to study drug in the clinical study program (456 in placebo-controlled trials). A total of 424 patients were treated with Sintaser at doses 1.2 mg/kg/day or 3.4 mg/kg/day for 3 or 6 months. Of these, 63% of patients were aged 91-150 days and 37% were aged 35-90 days at randomization.

The following table lists according to the dosage the most common adverse reactions (treatment-emergent adverse events with an incidence at least 3% greater on one of the two doses than on placebo).

Table 2: Treatment-emergent adverse events occurring at least 3% more often on Sintaser than on placebo.

Reaction	Placebo N=236	Sintaser 1.2 mg/kg/day N=200	Sintaser 3.4 mg/kg/day N=224
Sleep disorder	5.90%	17.50%	16.10%
Bronchitis	4.7	8	13.4
Peripheral coldness	0.4	8	6.7
Agitation	2.1	8.5	4.5
Diarrhea	1.3	4.5	6.3
Somnolence	0.4	5	0.9
Nightmare	1.7	2	6.3
Irritability	1.3	5.5	1.3
Decreased appetite	0.4	2.5	3.6
Abdominal pain	0.4	3.5	0.4

The following adverse events have been observed during clinical studies, with an incidence of less than 1%:

Cardiac disorders: Second degree atrioventricular heart block, in a patient with underlying conduction disorder, required definitive treatment discontinuation.

Skin and subcutaneous tissue disorders: Urticaria, alopecia

Investigations: Decreased blood glucose, decreased heart rate

Compassionate Use Program

More than 600 infants received Sintaser in a compassionate use program (CUP). Mean age at treatment initiation was 3.6 months. Mean dose of Sintaser was 2.2 mg/kg/day and mean treatment duration was 7.1 months.

The adverse reactions reported in the CUP were similar to the ADRs observed during clinical trials but some were more severe.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Sintaser. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

These adverse reactions are as follows:

Blood and lymphatic system disorders: Agranulocytosis

Psychiatric disorders: Hallucination

Skin and subcutaneous tissues disorders: Purpura

What is the most important information I should know about Sintaser?

• Sintaser concentrate may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Sintaser concentrate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Sintaser concentrate may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
• Sintaser concentrate may mask the signs of hyperthyroidism (overactive thyroid). If you have an overactive thyroid and stop taking Sintaser concentrate too suddenly, symptoms of hyperthyroidism (eg, fast heartbeat) may occur.
• Patients with a history of severe allergic reactions may be more sensitive to allergens while taking Sintaser concentrate. These patients may not respond to the usual dose of epinephrine (adrenalin).
• Diabetes patients - Sintaser concentrate may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Tell your doctor or dentist that you take Sintaser concentrate before you receive any medical or dental care, emergency care, or surgery.
• Sintaser concentrate may interfere with certain lab tests, including the glaucoma screening test. Be sure your doctor and lab personnel know you are taking Sintaser concentrate.
• Lab tests, including blood pressure and heart function tests, may be performed while you use Sintaser concentrate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Sintaser concentrate in CHILDREN; they may be more sensitive to its effects, especially breathing problems and high blood sugar levels.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sintaser concentrate while you are pregnant. Sintaser concentrate is found in breast milk. If you are or will be breast-feeding while you use Sintaser concentrate, check with your doctor. Discuss any possible risks to your baby.

If you suddenly stop taking Sintaser concentrate, you may experience WITHDRAWAL symptoms, including worsening chest pain along with possible heart attack.

Sintaser contraindications

Sintaser must not be used if there is a history of bronchial asthma or bronchospasm.

Bronchospasm can usually be reversed by beta-2 agonist bronchodilators such as salbutamol. Large doses of the beta-2-agonist bronchodilator may be required to overcome the beta-blockade produced by Sintaser and the dose should be titrated according to the clinical response; both intravenous and inhalational administration should be considered. The use of intravenous aminophylline and/or the use of ipratropium, (given by nebuliser), may also be considered. Glucagon (1 to 2 mg given intravenously) has also been reported to produce a bronchodilator effect in asthmatic patients. Oxygen or artificial ventilation may be required in severe cases.

Sintaser as with other beta-blockers must not be used in patients with any of the following: Known hypersensitivity to the substance; bradycardia; cardiogenic shock; hypotension; metabolic acidosis; after prolonged fasting; severe peripheral arterial circulatory disturbances; second or third degree heart block; sick sinus syndrome; untreated (with an alpha adrenoceptor antagonist) phaeochromocytoma; uncontrolled heart failure; Prinzmetal's angina.

Sintaser must not be used in patients prone to hypoglycaemia, i.e., patients after prolonged fasting or patients with restricted counter-regulatory reserves. Patients with restricted-counter regulatory reserves may have reduced autonomic and hormonal responses to hypoglycaemia which includes glycogenolysis, gluconeogenesis and/or impaired modulation of insulin secretion. Patients at risk for an inadequate response to hypoglycaemia includes individuals with malnutrition, prolonged fasting, starvation, chronic liver disease, diabetes and concomitant use of drugs which block the full response to catecholamines.

References

1. European Chemicals Agency - ECHA. "propranolol: The European Chemicals Agency (ECHA) is an agency of the European Union which is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness.". https://echa.europa.eu/ (accessed September 17, 2018).
2. NCIt. "Propranolol: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
3. NIST. "Propranolol". http://www.nist.gov/srd/nist1a.cfm (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Sintaser 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 Sintaser. 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.

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Information checked by Dr. Sachin Kumar, MD Pharmacology