Doxycycline Biogaran Side effects

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What are the possible side effects of Doxycycline Biogaran?

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

Call your doctor at once if you have:

Common Doxycycline Biogaran side effects may include:

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 Doxycycline Biogaran in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Clinical Trial Experience

The safety and efficacy of Doxycycline Biogaran Hyclate Delayed-Release Tablets, 200 mg as a single daily dose was evaluated in a multicenter, randomized, double-blind, active-controlled study. Doxycycline Biogaran Hyclate Delayed-Release Tablets 200 mg was given orally once-a-day for 7 days and compared to Doxycycline Biogaran hyclate capsules 100 mg given orally twice daily for 7 days for the treatment of men and women with uncomplicated urogenital C. trachomatis infection.

Adverse events in the Safety Population were reported by 99 (40.2%) subjects in the Doxycycline Biogaran Hyclate Delayed-Release Tablets, 200 mg treatment group and 132 (53.2%) subjects in the doxycyclinehyclate capsules reference treatment group. Most AEs were mild in intensity. The most commonly reported adverse events in both treatment groups were nausea, vomiting, diarrhea, and bacterial vaginitis, Table 1.

Table 1: Adverse Reactions Reported in Greater than or Equal to 2% of Subjects

Doxycycline Biogaran Hyclate Delayed-Release Tablets, 200 mg

N = 246

Preferred Term n (%)
Subjects with any AE 99 (40.2)
Nausea 33 (13.4)
Vomiting 20 (8.1)
Headache 5 (2.0)
Diarrhea 8 (3.3)
Abdominal Pain Upper 5 (2.0)
Vaginitis Bacterial 8 (3.3)
Vulvovaginal Mycotic Infection 5 (2.0)

Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not always reflect the rates observed in practice.

Postmarketing Experience

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

Due to oral Doxycycline Biogaran's virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines:

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of drugs in the tetracycline-class. Most of these patients took medications immediately before going to bed.

Skin: Maculopapular and erythematous rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and erythema multiforme have been reported. Photosensitivity is discussed above.

Renal: Rise in BUN has been reported and is apparently dose-related.

Hypersensitivity reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

Intracranial Hypertension: Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracycline

Thyroid Gland Changes: When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function are known to occur.

What is the most important information I should know about Doxycycline Biogaran?

Doxycycline Biogaran contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Do not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Doxycycline Biogaran can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using Doxycycline Biogaran.

You should not take this medicine if you are allergic to Doxycycline Biogaran or to other tetracycline antibiotics such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

Before taking Doxycycline Biogaran, tell your doctor if you have liver disease, kidney disease, asthma, or if you are allergic to sulfites.

Drink plenty of liquids while you are taking Doxycycline Biogaran.

Children should not use Doxycycline Biogaran. Doxycycline Biogaran can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.


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References

  1. DailyMed. "DOXYCYCLINE: 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. European Chemicals Agency - ECHA. "Doxycycline Hyclate: 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).
  3. HSDB. "DOXYCYCLINE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Doxycycline Biogaran 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 Doxycycline Biogaran. 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

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