Angoron Side effects

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

What are the possible side effects of Angoron?

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

Angoron takes a long time to completely clear from your body. You may continue to have side effects from Angoron after you stop using it. It could take up to several months for the medicine to completely clear from your body.

Call your doctor at once if you have any of these side effects, even if they occur up to several months after you stop using Angoron:

• a new or a worsening irregular heartbeat pattern;

• fast, slow, or pounding heartbeats;

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

• wheezing, cough, chest pain, trouble breathing, coughing up blood;

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

• blurred vision, vision loss, headache or pain behind your eyes, sometimes with vomiting;

• swelling, pain, redness, or irritation around your IV needle;

• weight loss, thinning hair, feeling too hot or too cold, increased sweating, irregular menstrual periods, swelling in your neck (goiter);

• pain in your upper stomach, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• little or no urinating.

Common Angoron side effects may include:

• low fever;

• slight dizziness; or

• mild nausea, vomiting.

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 Angoron in details

Eyes: Microdeposits at the anterior surface of the cornea are found in almost every patient, are usually limited to the area below the pupil and may occasionally lead to visual disturbances (blurring of vision, visual haloes). They usually regress 6-12 months after discontinuation of Angoron.

Some cases of optic neuritis-which caused permanent blindness in isolated cases - have been reported.

During treatment with Angoron, regular ophthalmic examinations (including funduscopy and examinations by means of a slit-lamp) are therefore indicated.

Skin: Occasionally, photosensitization with increased tendency to sunburns may occur, which can lead to erythema and rash.

During longer-term treatment, especially body areas exposed to sunlight may become hyperpigmentated with black-violet to slate-grey discoloration of the skin (pseudocyanosis).

The discoloration slowly recedes within 1-4 years after discontinuing the preparation.

Cases of erythematous development on radiation therapy have been reported. Cases of erythema nodosum and rarely specific exanthemas including rare cases of exfoliative dermatitis have been reported.

Thyroid Gland: Angoron inhibits the transformation of thyroxine (T4) into triiodothyronine (T3) and may lead to increased T4 values as well as to decreased T3 values in clinically inconspicuous (erythroid) patients.

Occasionally, thyroid dysfunctions (hyperthyroidism or hypothyroidism) occur.

The Following Conditions May Point to Thyroid Dysfunction: In Hypothyroidism: Weight gain, exhaustion, extreme bradycardia, exceeding effect expected on Angoron. In Hyperthyroidism: Weight loss, tachycardia, tremor, nervousness, increases diaphoresis and heat intolerance, recurrence of arrhythmias or angina pectoris, cardiac insufficiency.

Severe hyperthyroidism, in isolated cases leading to death, has been described.

Lung: As a result of the pulmonary toxicity of Angoron, atypical pneumonia as symptom of a hypersensitivity reaction (hypersensitivity pneumonitis), alveolar or interstitial pneumonitis or fibroses, pleuritis, bronchiolitis obliterans with pneumonia/BOOP may occur.

Non-productive cough and dyspnea are often the first signs of the pulmonary alterations that subside. Furthermore, weight loss, fever, asthenia may occur.

If Angoron is discontinued in good time, the previously mentioned pulmonary alterations subside. Isolated cases with lethal course have been reported.

Mostly after surgical procedures, several cases of shock lung (ARDS), which were fatal in isolated cases, occurred.

Gastrointestinal Tract/Liver: Nausea and vomiting frequently occur. Occasionally, abdominal pain sensation of repletion, constipation and anorexia occur.

Occasionally, isolated increases in serum transaminases occur, which are usually not very pronounced.

Rare cases of acute hepatitis (in isolated cases leading to death), cholestatic icterus or hepatocirrhosis have been described.

In cases of persistent clinically relevant increases in liver enzymes, cholestatic icterus or hepatomegalia, discontinuation of Angoron should be taken into consideration.

Heart: As a result of the pharmacological effect of Angoron, sinus bradycardia - which may be pronounced in elderly patients or in cases of disturbed sinus node function - or, in exceptional cases, sinus node arrest may occur. The ECG shows the following alterations: QT prolongation, occurrence of a U-wave, prolongation or deformation of the T-wave.

Therapy must be withdrawn if pronounced bradycardia or sinus node arrest occurs.

In rare cases, conduction disturbances occurs (SA block, AV block); in isolated cases, the occurrence of asystole has been observed.

Pro-arrhythmic effects in the form of alterations or aggravations of arrhythmias have been observed, which can lead to highly impaired cardiac activity with the possible consequence of cardiac arrest.

Isolated cases of Torsades de pointes and ventricular fibrillation/flutter have been described.

Other Adverse Effects: Occasionally, fatigue, headache, dyssomnia, nightmares, vertigo, diminished libido, myasthenia, tremor, impaired coordination paraesthesia, peripheral neuropathy or ataxia occur. Rarely, dysgeusia as well as reversible alopecia occur.

Rarely, hypersensitivity reactions as well as vasculitis, thrombocytopenia, transiently impaired renal function and epididymitis may occur.

Isolated cases of hemolytic or aplastic anemia as well as intracranial increase in pressure (cerebral-pseudo-tumor) have been reported.

Isolated cases of a syndrome of inappropriate (increased) secretion of antidiuretic hormone (SIADH) with hyponatremia have been described in connection with Angoron.

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

• Tell your doctor or dentist that you take Angoron Injection Solution before you receive any medical or dental care, emergency care, or surgery, including laser surgery on the eye.
• Angoron Injection Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Angoron Injection Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Angoron Injection Solution stays in your body for some time if you have to stop taking it. If you stop taking Angoron Injection Solution, be sure to tell your doctor and pharmacist that you took Angoron Injection Solution before starting other medicines. Discuss any questions or concerns with your doctor.
• Severe and sometimes fatal lung or breathing problems have been reported with Angoron Injection Solution. Contact your doctor right away if you develop shortness of breath, chest pain, wheezing, fever, or cough, or if you begin coughing up blood.
• Angoron Injection Solution may cause vision problems that may lead to permanent blindness. Contact your doctor right away if you experience vision changes (eg, seeing halos, blurred vision, loss of vision).
• Limit alcoholic beverages while taking Angoron Injection Solution.
• Tell your doctor if you have severe or persistent diarrhea while you are taking Angoron Injection Solution. You will need to take care not to become dehydrated.
• New or worsening irregular heartbeat, life-threatening lung problems, and serious liver problems may occur with Angoron Injection Solution. Therefore, it should only be given to patients with life-threatening heartbeats who cannot tolerate other medicines.
• Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. They can cause serious health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Your doctor may want you to check your pulse rate every day while you take Angoron Injection Solution. Learn how to monitor your pulse.
• Carry an ID card at all times that says you take Angoron Injection Solution.
• Lab tests, including electrocardiograms (ECGs), blood pressure, chest x-rays, lung function tests, liver function tests, thyroid function tests, and eye exams, may be performed while you use Angoron Injection Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Angoron Injection Solution with caution in the ELDERLY; they may be more sensitive to its effects, especially slow heartbeat.
• Angoron Injection Solution should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. Angoron Injection Solution has benzyl alcohol in it. Do not use it in NEWBORNS and INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.
• DEHP, a chemical found in plastic intravenous tubing, may cause harm in young CHILDREN (male reproductive system effects). Angoron Injection Solution can cause DEHP to leach out of the tubing. If Angoron Injection Solution is used in a child, discuss any questions or concerns with your doctor.
• PREGNANCY and BREAST-FEEDING: Angoron Injection Solution has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Angoron Injection Solution while you are pregnant. Angoron Injection Solution is found in breast milk. Do not breast-feed while taking Angoron Injection Solution.

Angoron contraindications

Known hypersensitivity to iodine, Angoron or to one of the excipients of Angoron. Sinus bradycardia and sinoatrial heart block without a prosthesis. Sinus node disease without a prosthesis (risk of sinus arrest). High-degree atrioventricular conduction disorders without a prosthesis. Hyperthyroidism because of possible exacerbation by Angoron.

Combination with Angoron liable to induce Torsade de pointes: Class Ia antiarrhythmics (quinidine, hydroquinidine, disopyramide), class III antiarrhythmics (sotalol, dofetilide, ibutilide), other medicinal products, eg, bepridil, cisapride, diphemanil, erythromycin IV, mizolastine, moxifloxacin, spiramycin IV, vincamine IV,, sultopride.

Injection: Circulatory collapse; severe arterial hypotension; bi- or tri-fascicular conduction disorders, unless a permanent functioning pacemaker is fitted or, unless the patient is in a special care unit and Angoron is used under the cover of electrosystolic pacing; hypotension, severe respiratory failure, myocardiopathy or heart failure (possible worsening).

These contraindications do not apply to the use of Angoron for CPR in the event of cardiac arrest related to ventricular fibrillation resistant to external electric shock.

Use in Children: The safety and efficacy of Angoron in pediatric patients have not been established. Therefore, its use in pediatric patients is not recommended.

Children <3 years: Due to the presence of benzyl; Angoron must not be given to newborns or premature neonates.

Use in Pregnancy: Animal studies have not demonstrated any teratogenic effects. In the absence of a teratogenic effect in animals, no teratogenic effects are expected in humans. To date, substances causing malformations in humans have been shown to be teratogenic in animals during studies conducted properly in 2 species.

In a clinical context, there are not yet enough relevant data in order to evaluate the possible teratogenic effect of Angoron when administered during the 1st trimester of pregnancy. Since the fetal thyroid gland begins to bind iodine from week 14 of amenorrhea, no effects on the fetal thyroid gland are expected in the event of previous administration. Iodine overload with the use of this product beyond this period may give rise to biological or clinical (goiter) fetal hypothyroidism. In view of its effects on the fetal thyroid gland, Angoron is contraindicated during pregnancy, except if the benefits outweigh the risks.

Use in Lactation: Angoron is excreted in breast milk in significant quantities and is therefore contraindicated in breastfeeding mothers. Angoron and its metabolite, together with iodine, are excreted in breast milk at concentrations greater than those in maternal plasma. Due to the risk of hypothyroidism in the newborn infant, breastfeeding is contraindicated in the event of treatment with Angoron.

References

1. European Chemicals Agency - ECHA. "Amiodarone: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
2. HSDB. "AMIODARONE HYDROCHLORIDE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
3. NCIt. "Amiodarone: 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).

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Information checked by Dr. Sachin Kumar, MD Pharmacology