The reference site for Roxithromycin

Roxithromycin is a semi-synthetic macrolide antibiotic. It is used to treat respiratory tract, urinary and soft tissue infections.

WHAT IS ROXITHROMYCIN?

Roxithromycin is a semi-synthetic macrolide antibiotic. It is often prescribed for several different infections, including some STDs, upper and lower respiratory tract infections and asthma, gum infections like gingivitis, urinary and soft tissue infections, and bacterial infections associated with stomach and intestinal ulcers.

It is available under several brand names, including Surlid®, Rulide®Biaxsig®Roxar® and Roximycin®.

 

Brand Name(s): Surlid; Rulide; Biaxsig; Roxar; Roximycin; Roxy; Roxicate; Tirabicin
CAS nº: 80214-83-1
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Product Info

The sections below will provide you with more specific information and guidelines related to roxithromycin and its correct use. Please read them carefully.

FDA Information

The German pharmaceutical company, Hoechst AG, first discovered roxithromycin in 1987. This life-sciences company then became Aventis after its merger with Rhône-Poulenc S.A. in 1999.

This particular antibiotic medication has been approved as a prescription drug in Latin America and Europe. However, the US FDA has not yet approved it in the US.

Please visit the official site of the FDA for further information.

Why is this medication prescribed?

Antibiotics such as roxithromycin can often be prescribed for several different infections, including some STDs, upper and lower respiratory tract infections and asthma, gum infections like gingivitis, urinary and soft tissue infections, and bacterial infections associated with stomach and intestinal ulcers.

Roxithromycin is very similar in composition, chemical structure (semi-synthetic) and mechanism of action to erythromycin, azithromycin, or clarithromycin.  It containing the same 14-membered lactone ring with the addition of an N-oxime side chain.

Mechanism of Action:

Roxithromycin prevents bacteria from growing, by interfering with their protein synthesis. Roxithromycin binds to the subunit 50S of the bacterial ribosome, and thus inhibits the translocation of peptides. Roxithromycin has similar antimicrobial spectrum as erythromycin, but is more effective against certain gram-negative bacteria, particularly Legionella pneumophila.

Other uses for this medicine

This medication has not been approved for any alternative uses other than those mentioned in the product information section.

Dosage and using this medicine

Roxithromycin is commonly administered in tablets or granules for oral suspension.

USAGE

Roxithromycin should be taken at least 15 minutes before food or on an empty stomach (ie. more than 3 hours after a meal). Roxithromycin works best if you take it on an empty stomach.

Swallow roxithromycin tablets whole, and with a full glass of water.

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information you read. If you do not understand the instructions on the box, then please ask your doctor or pharmacist for help.

DOSAGE

For Adults:
The usual adult dosage is 300 mg per day either as a single dose (300 mg tablet), or in two divided doses (150 mg tablet every 12 hours). The usual duration of treatment is 7-10 days depending on the indication and clinical response. A small proportion of those with non-gonococcal genital infections may require 20 days for a cure.

In patients with documented cirrhotic liver disease, the dosage should be reduced to 150 mg once daily.

In the elderly and those with renal failure, dosage reduction is not required for the normally short course of treatment.

For Children:
The dosage of roxithromycin given to children is dependant on the child’s weight. Children under 4 years of age should not take roxithromycin.

What special precautions should I follow?

BEFORE TAKING ROXITHROMYCIN:

Tell your doctor if you are using any of the following drugs: cyclosporin,
ranitidine/antacids, carbamazepine, magnesium hydroxide, oral contraceptives, theophylline, disopyramide, ergot alkaloids, warfarin, digoxin, midazolam,  or terfenadine. If you are using any of these drugs, you may not be able to use ropinirole, or you may need dosage adjustments or special tests during treatment.

Moreover, please inform your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

The serum half-life of roxithromycin is increased in patients with hepatic failure. In severe hepatic insufficiency (e.g. hepatic cirrhosis with jaundice and/or ascites), the dose should be reduced by half i.e. roxithromycin 150 mg once daily.

Special caution is needed when driving or using heavy machines, as this medication can cause dizziness.

Use in Pregnancy: safety of the foetus has not been established during pregnancy. However, studies in several animal species have not shown any teratogenic or foetotoxic action with doses up to 200 mg/kg/day, or 40 times the human therapeutic dose.

Use in Lactation: small amounts of roxithromycin are excreted into human breast milk (less than 0.05% of the dose ingested). Therefore, breast-feeding or treatment of the mother should be stopped if required.

What should I do if I forget a dose?

If it is almost time for your next dose, skip the dose you missed and take your next scheduled dose when required. Otherwise, take it as soon as you remember, and then go back to taking your tablets as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist. It is strongly advised not to take a double dose to make up for the dose that you missed.

What side effects can this medication cause?

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.

If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after roxithromycin has been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel and you may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.

If you get a sore, white mouth or tongue while taking or soon after stopping roxithromycin, tell your doctor or pharmacist.

Also tell your doctor or pharmacist if you get vaginal itching or discharge. This may mean you have a fungal/yeast infection called thrush. Sometimes the use of roxithromycin allows fungi/yeast to grow and the above symptoms to occur, and this medication does not work against fungi/yeast.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking roxithromycin. It helps many people with bacterial infections, but it may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not, and medical treatment may be required for some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have regarding side effects.

Tell your doctor if you notice any of the following and they worry you:

* oral thrush – white, furry, sore tongue and mouth
* vaginal thrush – sore and itchy vagina and/or discharge
* nausea, vomiting, stomach pain, diarrhoea, flatulence
* loss of appetite
* red and/or itchy skin
* headache, dizziness, ringing in the ears
* tiredness
* altered taste

Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:

* swelling of the face, lips, mouth and tongue
* severe persistent diarrhoea
* an allergic reaction (for example, itchy skin, rash, swelling, asthma)

These may be signs of a serious allergic reaction. Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

After finishing taking this medicine, tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with roxithromycin:

* severe abdominal cramps or stomach cramps
* watery and severe diarrhoea, which may also be bloody
* fever, in combination with one or both of the above

These are rare but serious side effects. You may have a serious condition affecting your bowel and you may need urgent medical attention.

Some people may get other side effects while taking roxithromycin. Do not be alarmed by this list of possible side effects as most people do not experience any of them.

What storage conditions are needed for this medicine?

Always keep your tablets in the blister pack until it is time to take them. Keep roxithromycin in a cool dry place where the temperature stays below 30°C.

Moreover, keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres (5 ft) above the ground is a good place to store medicines.

Furthermore, do not store it or any other medicine in the bathroom, near a sink, in the car or on window sills. Heat and dampness can destroy some medicines.

In case of an emergency/overdose

In the case of a suspected overdose, call your local poison control center on 1-800-222-1222. However, if the victim has collapsed or is not breathing, then please call the local emergency services immediately on 911.

Symptoms of an overdose from roxithromycin are not currently known.

Product Images

PICTURES OF ROXITHROMYCIN PILLS

Below you will find images and specific information on the principal types of roxithromycin that exist, including their respective brand name(s), strength, inscription codes, manufacturers and/or distributors.

The information below includes general information and guidelines for patients taking this medication and should never be used to substitute professional medical advice that can be provided by a qualified physician or family doctor.

Name: RULIDE®
Strength(s): 150 MG
Imprint: Rulide 150
Manufacturer: AVENTIS

Name: ROXICATE®
Strength(s): 150 MG
Imprint: Roxithromycin Tablets
Manufacturer: MERIDIAN

Name: ROXY®
Strength(s): 150 MG
Imprint: Roxithromycin Comprimes
Manufacturer: SHALINA

Name: RULIDE®
Strength(s): 300 MG
Imprint: Rulide 300
Manufacturer: AVENTIS

Name: ROXY®
Strength(s): 300 MG
Imprint: Roxithromycin Comprimes
Manufacturer: SHALINA

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