Sinozol Side effects

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

What are the possible side effects of Sinozol?

Get emergency medical help if you have any signs of an allergic reaction to Sinozol: hives, severe skin rash, tingling in your arms or legs; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking Sinozol and call your doctor at once if you have:

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

• confusion, ringing in your ears, problems with hearing;

• fast heartbeats;

• numbness or tingly feeling, blurred vision, double vision, loss of bladder control;

• severe pain in your upper stomach spreading to your back, nausea and vomiting;

• little or no urinating, pain or burning when you urinate;

• signs of congestive heart failure--shortness of breath (even with mild exertion), cough with mucus, fast heartbeats, swelling, rapid weight gain, sleep problems; or

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

Common side effects may include:

• headache, dizziness;

• nausea, vomiting, upset stomach, constipation;

• hair loss;

• fever, muscle aches, joint pain;

• changes in your menstrual periods;

• impotence, erection problems; or

• unusual or unpleasant taste in the mouth.

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 Sinozol in details

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Sinozol has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. The risks and benefits of Sinozol use should be reassessed.

Adverse Events Reported in Oropharyngeal or Esophageal Candidiasis Trials

U.S. adverse experience data are derived from 350 immunocompromised patients (332 HIV seropositive/AIDS) treated for oropharyngeal or esophageal candidiasis. Table 2 below lists adverse events reported by at least 2% of patients treated with Sinozol

Oral Solution in U.S. clinical trials. Data on patients receiving comparator agents in these trials are included for comparison.

Table 2: Summary of Adverse Events Reported by ≥2% of ItraconazoleTreated Patients in U.S. Clinical Trials (Total)

* Of the 350 patients, 209 were treated for oropharyngeal candidiasis in controlled studies, 63 were treated for esophageal candidiasis in controlled studies and 78 were treated for oropharyngeal candidiasis in an open study.

† Of the 125 patients, 62 were treated for oropharyngeal candidiasis and 63 were treated for esophageal candidiasis.

‡ All 81 patients were treated for oropharyngeal candidiasis.

Adverse events reported by less than 2% of patients in U.S. clinical trials with Sinozol included: adrenal insufficiency, asthenia, back pain, dehydration, dyspepsia, dysphagia, flatulence, gynecomastia, hematuria, hemorrhoids, hot flushes, implantation complication, infection unspecified, injury, insomnia, male breast pain, myalgia, pharyngitis, pruritus, rhinitis, rigors, stomatitis ulcerative, taste perversion, tinnitus, upper respiratory tract infection, vision abnormal, and weight decrease. Edema, hypokalemia and menstrual disorders have been reported in clinical trials with Sinozol capsules.

Adverse Events Reported from Other Clinical Trials

A comparative clinical trial in patients who received intravenous Sinozol followed by Sinozol

Oral Solution or received Amphotericin B reported the following adverse events in the Sinozol intravenous/ Sinozol

Oral Solution treatment arm which are not listed above in the subsection “Adverse Events Reported in Oropharnyngeal or Esophageal Candidiasis Trials” or listed below as postmarketing reports of adverse drug reactions: serum creatinine increased, blood urea nitrogen increased, renal function abnormal, hypocalcemia, hypomagnesemia, hypophosphatemia, hypotension, tachycardia and pulmonary infiltration.

In addition, the following adverse drug reactions were reported in patients who participated in Sinozol

Oral Solution clinical trials:

Cardiac Disorders: cardiac failure;

General Disorders and Administration Site Conditions: edema;

Hepatobiliary Disorders: hepatic failure, hyperbilirubinemia;

Metabolism and Nutrition Disorders: hypokalemia;

Reproductive System and Breast Disorders: menstrual disorder

The following is a list of additional adverse drug reactions associated with Sinozol that have been reported in clinical trials of Sinozol capsules and Sinozol IV excluding the adverse reaction term “Injection site inflammation” which is specific to the injection route of administration:

Cardiac Disorders: left ventricular failure;

Gastrointestinal Disorders: gastrointestinal disorder;

General Disorders and Administration Site Conditions: face edema;

Hepatobiliary Disorders: jaundice, hepatic function abnormal;

Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, blood

alkaline phosphatase increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, urine analysis abnormal;

Metabolism and Nutrition Disorders: hyperglycemia, hyperkalemia;

Nervous System Disorders: somnolence;

Psychiatric Disorders: confusional state;

Renal and Urinary Disorders: renal impairment;

Respiratory, Thoracic and Mediastinal Disorders: dysphonia;

Skin and Subcutaneous Tissue Disorders: rash erythematous;

Vascular Disorders: hypertension

In addition, the following adverse drug reaction was reported in children only who participated in Sinozol

Oral Solution clinical trials: mucosal inflammation.

Post-marketing Experience

Adverse drug reactions that have been first identified during post-marketing experience with Sinozol (all formulations) are listed in the table below. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.

Table 3: Postmarketing Reports of Adverse Drug Reactions

There is limited information on the use of Sinozol during pregnancy. Cases of congenital abnormalities including skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations have been reported during post-marketing experience. A causal relationship with Sinozol has not been established.

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

• Sinozol tablets may cause dizziness or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Sinozol tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. If you have dizziness or vision changes, do not drive or perform other possibly unsafe tasks.
• Rarely, Sinozol tablets has been associated with serious and sometimes fatal liver problems, including some cases within the first week of treatment. Contact your doctor right away if you notice dark urine; loss of appetite; pale stools; severe stomach pain; unusual tiredness, nausea, or vomiting; or yellowing of the skin or eyes.
• Hearing loss has been reported in patients taking Sinozol tablets. Many of these cases have occurred when Sinozol tablets has been taken along with quinidine. The hearing loss usually goes away when Sinozol tablets is stopped but may persist in some patients. Discuss any questions or concerns with your doctor.
• Sinozol tablets only works against fungi; it does not treat viral infections (eg, the common cold).
• Be sure to use Sinozol tablets for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Sinozol tablets may interact with many other medicines. This includes how well Sinozol tablets works or increased side effects. Sometimes this may lead to life-threatening effects or sudden death. Be sure your doctor and pharmacist know all of the medicines that you take.
• Do not switch to other forms of Sinozol tablets (eg, capsules, oral solution) without checking with your doctor. Effectiveness and side effects of these forms of Sinozol tablets may be different even at the same dose.
• Diabetes patients - Sinozol tablets may increase the risk of low blood sugar from your diabetes medicine. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Sinozol tablets. To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Women who are able to become pregnant should use an effective form of birth control while taking Sinozol tablets and for 2 months after stopping Sinozol tablets. Talk with your doctor about effective forms of birth control.
• Tell your doctor or dentist that you take Sinozol tablets before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including liver function, may be performed while you use Sinozol tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Sinozol tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially loss of hearing.
• Sinozol tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Sinozol tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sinozol tablets while you are pregnant. Sinozol tablets is found in breast milk. If you are or will be breast-feeding while you use Sinozol tablets, check with your doctor. Discuss any possible risks to your baby.

Sinozol contraindications

Drug Interactions

Concomitant administration of Sinozol® (Sinozol) Capsules, Injection, or

Oral Solution and certain drugs metabolized by the cytochrome P450 3A4 isoenzyme system (CYP3A4) may result in increased plasma concentrations of those drugs, leading to potentially serious and/or life-threatening adverse events. Cisapride, oral midazolam, nisoldipine, pimozide, quinidine, dofetilide, triazolam and levacetylmethadol (levomethadyl) are contraindicated with Sinozol® (Sinozol injection). HMG CoA-reductase inhibitors metabolized by CYP3A4, such as lovastatin and simvastatin, are also contraindicated with Sinozol® (Sinozol injection). Ergot alkaloids metabolized by CYP3A4 such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) are contraindicated with Sinozol®.

Sinozol® (Sinozol injection) is contraindicated for patients who have shown hypersensitivity to Sinozol or its excipients. There is no information regarding cross-hypersensitivity between Sinozol and other azole antifungal agents. Caution should be used when prescribing Sinozol® (Sinozol injection) to patients with hypersensitivity to other azoles.

Sinozol IV cannot be used when administration of Sodium Chloride Injection is contraindicated.

The excipient hydroxypropyl-β-cyclodextrin is eliminated through glomerular filtration. Therefore, Sinozol IV is contraindicated in patients with severe renal impairment (defined as creatinine clearance below 30 mL/min).

References

1. DailyMed. "ITRACONAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DTP/NCI. "itraconazole: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "(±)-cis-4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2,4-dihydro-2-sec-butyl-3H-1,2,4-triazol-3-one: 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).

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Information checked by Dr. Sachin Kumar, MD Pharmacology