Tetralysal – composition, action, indications, contraindications, dosage

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Tetralysal is a prescription-only antibiotic drug. Due to the limecycline it contains, this preparation is mainly used in the treatment of acne vulgaris and rosacea. What are the contraindications to the use of this preparation? Can the use of Tetralysal cause side effects? How to dose this preparation? Can other medications be used at the same time?

Tetralysal – general characteristics of the drug

Tetralysal is a drug from the group of antibiotics belonging to the tetracyclines. This preparation is used in the treatment of diseases in the field of dermatology and venereology.

Tetralysal is available from pharmacies as hard capsules. It is available in doses of Tetralysal 300 mg and 150 mg, in packs of 16. The product cannot be purchased over-the-counter and is non-refundable.

The active substance of Tetralysal is limecycline, which is used in the treatment of common acne of medium and high severity, with inflammatory changes such as papules, pustules, nodules, cysts, infiltrates and in the treatment of rosacea.

The pharmaceutical company is responsible for the production and distribution of Tetralysal Galderma Poland. The company was founded in 1981 as a joint venture between Nestle and L’Oreal. From 2014 to September 2019, it was operated as Nestle Skin Health, part of the Nestle SA group. From October 2019, Galderma is an independent company managed by a consortium of investors: EQT, Luxinva – a subsidiary of Abu Dhabi Investment Authority (ADIA), and PSP Investment . The concern has been operating on the Polish market since 2000.

What are antibiotics and how do they work? Read on: Antibiotics – types, action, use and side effects [EXPLAIN]

Tetralysal – composition and action

Tetralysal is a broad-spectrum antibacterial and anti-inflammatory antibiotic. The active substance of this preparation is limecycline.

Limecycline is an antibiotic that belongs to the tetracycline group. The mechanism of action of limecycline is to inhibit the biosynthesis of proteins in bacterial cells. Limecycline is bacteriostatic antibioticbecause its action does not kill bacteria but only inhibits cell growth.

Limecycline is distinguished by a wide spectrum of activity, which means that it is active against many species of bacteria. This drug is anti-inflammatory, inhibits the activity of multinucleated granulocytes, inactivates bacterial lipases and impairs the synthesis of new enzyme molecules, which inhibits the production of free fatty acids that irritate the skin.

After oral administration, limecycline is rapidly absorbed from the gastrointestinal tract. The maximum plasma concentration is reached after approx. 3 hours. The biological half-life is approximately 10 hours. This compound is mainly excreted in the urine, and to a lesser extent in the bile. Approx. 65% of the administered dose is excreted within 48 hours.

The other ingredients of Tetralysal are:

1. magnesium stearate;
2. hydrated silica precipitate;
3. corn starch;
4. lactose.

The gelatin capsule also contains:

1. gelatine;
2. titanium dioxide;
3. erythrozyna;
4. quinoline yellow.

What is worth knowing about antibiotics used for acne? Read: Antibiotic for acne – how acne arises, treatment, contraindications

Tetralysal – indications for use

Tetralysal is usually used as an antibiotic for moderate to severe acne vulgaris. It is prescribed for patients with inflammatory skin lesions, such as papules, pustules, nodules, infiltrates, and cysts. This drug is also used in the treatment of rosacea.

To treat acne, Tetralysal works:

1. antibacterial against the microorganism Propionibacterium acnes;
2. anti-inflammatory (by inhibiting the activity of certain types of white blood cells); 
3. by inhibiting the bacterial enzyme that produces free fatty acids, which are irritating.  

What acne cream can be effective? Check: Cream for acne – composition, action. Which acne cream should you choose?

Tetralysal – contraindications to the use of the drug

Tetralysal, despite its effectiveness in the treatment of acne, cannot be used by every patient struggling with this type of ailments.

Contraindications to the use of Tetralysal are:

1. allergy to limecycline or any of the other excipients of the drug;
2. allergic reactions to other tetracycline antibiotics;
3. taking medications called retinoids;
4. age of the patient – the drug should not be used in children under 8 years of age (due to the risk of permanent changes in the teeth and discoloration of the enamel);
5. pregnancy and breastfeeding.

Learn the facts and myths about acne: Tradzik – fact i mity

Tetralysal – precautions

Before and during the use of Tetralysal, follow the precautions included in the package leaflet.

Precautions to keep in mind include:

1. the possibility of severe headaches;
2. drink plenty of fluids along with this medication;
3. taking Tetralysal may cause irritation and ulceration of the esophagus;
4. it is advisable to avoid sunlight and other sources of ultraviolet radiation;
5. if you experience diarrhea during treatment, see your doctor, it may be a symptom of pseudomembranous enteritis;
6. in the case of myasthenia gravis, the symptoms of the disease may worsen;
7. systemic lupus erythematosus;
8. impaired kidney or liver function;
9. the medicine should not be used after the expiry date which is stated on the carton. The expiry date refers to the last day of that month;
10. this medicine should not be disposed of via wastewater or household waste. It’s best to ask your pharmacist how to dispose of medicines you no longer use.

What should you know about proper drug storage? Check: Medications that are stored wrongly are poisonous

Tetralysal – drug dosage

Always use Tetralysal exactly as described in the package leaflet or as directed by your doctor or pharmacist.

Tetralysal is available as capsules for oral use. The capsules should be swallowed with plenty of water and kept upright to avoid damaging the esophagus. Taking food at the same time, including milk, does not significantly affect the absorption of Tetralysal.

For long-term treatment of acne vulgaris, the daily dose is 300 mg taken for 12 weeks. Treatment of rosacea requires a starting dose of 600 mg a day, which is taken for 10 days. For the next 3-6 months, a dose of 300 mg is taken. The final duration of treatment is determined by the doctor individually for each patient.

How to take medication correctly? Check: How to take medications effectively?

Tetralysal – side effects

Tetralysal, like any other drug, may cause side effects in patients. It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.

The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

Common side effects of Tetralysal have:

1. nausea;
2. abdominal pain;
3. diarrhea;
4. headache.

List side effects of unknown frequency occurrence is much longer. The following complaints are included in the Tetralysal leaflet:

1. vision problems: visual disturbances, double vision, and permanent loss of vision;
2. disorders observed within laboratory tests: thrombocytopenia, neutropenia, haemolytic anemia, eosinophilia, but also other haematological disorders;
3. vomiting;
4. pains in the upper abdomen;
5. inflammation of the small intestine and colon;
6. glossitis;
7. inflammation of the pancreas;
8. pseudomembranous enteritis;
9. fever;
10. vaginitis;
11. candidiasis;
12. blastomykoza;
13. hypersensitivity,
14. severe anaphylactic reactions;
15. angioedema;
16. hives;
17. jaundice;
18. hepatitis;
19. elevated levels of aminotransaminase activity;
20. increase in blood alkaline phosphatase;
21. elevated blood bilirubin;
22. intracranial hypertension;
23. dizziness;
24. sensitivity to light;
25. skin changes: itching, rash erythematous, rash, increased and persistent itching of the skin, Stevens-Johnson syndrome, dermatitis, as well as toxic epidermal necrolysis.

How to deal with acne? Read on: FAQ acne. A practical guide for anyone struggling with acne

Tetralysal and pregnancy and breastfeeding

The use of any medications or dietary supplements during pregnancy requires consultation with the attending physician. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Tetralysal.

The use of Tetralysal is contraindicated in pregnant women and during breast-feeding.

The use of tetracyclines, including limecyclines, during the development of the teeth and skeleton (pregnancy, children up to 12 years of age) may cause permanent discoloration of the enamel, damage to the teeth or delay in skeletal development.

What is worth knowing about proper supplementation during pregnancy? Check: Conscious choices. Diet and supplementation in pregnancy

Tetralysal – interactions with other drugs

Before starting treatment with Tetralysal, please inform your doctor or pharmacist about all the medicines you are taking or have taken recently. You should also inform what medications the patient plans to take in the near future.

The active substance in Tetralysal may interact with other drugs and substances contained in medical products. Therefore, this preparation should not be taken simultaneously with:

1. blood thinners;
2. drugs for the treatment of HIV;
3. other drugs to treat acne;
4. antibiotics;
5. retinoids and vitamin A products;
6. diuretics;
7. indigestion medications;
8. iron-containing drugs;
9. drugs for epilepsy;
10. drugs that reduce the amount of stomach acid;
11. antacids.

Which drugs should never be combined with each other? Check: Dangerous interactions

Tetralysal — cena

The price of Tetralysal may differ depending on the city in which the antibiotic will be purchased or the pharmacy chosen by the patient. The price of the product also depends on the amount of the active substance contained in the tablet:

1. 16 capsules, where 1 capsule contains 204 mg of limecycline, which corresponds to 150 mg of tetracycline, costs about PLN 17-18;
2. 16 capsules, where 1 capsule contains 408 mg of limecycline, which corresponds to 300 mg of tetracycline, costs about PLN 24-25.

How much money does the average Pole spend on treatment? Check: The Pole is not expected to see a doctor