Sumamed 1200 XL Uses

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What is Sumamed 1200 XL?

Sumamed 1200 XL injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV).

Sumamed 1200 XL belongs to the class of drugs known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, Sumamed 1200 XL will not work for colds, flu, or other virus infections. Sumamed 1200 XL injection may be used for other problems as determined by your doctor.

Sumamed 1200 XL is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Sumamed 1200 XL is used in certain patients with the following medical condition:

  • Trachoma (treatment).

Sumamed 1200 XL indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Sumamed 1200 XL extended-release granules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of designated microorganisms in the specific conditions listed as follows.

Adults: Acute uncomplicated bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.

Mild to moderate community-acquired pneumonia (CAP) due to Chlamydia pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae or Streptococcus pneumoniae.

Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. (Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis. Sumamed 1200 XL is often effective in the eradication of susceptible strains of Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to Sumamed 1200 XL, susceptibility tests should be performed when patients are treated with Sumamed 1200 XL). Data establishing efficacy of Sumamed 1200 XL in subsequent prevention of rheumatic fever are not available.

Pediatrics: Mild to moderate community-acquired pneumonia in pediatric patients 6 months of age or older due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae, in patients appropriate for oral therapy. Pediatric use in this indication is based on extrapolation of adult efficacy.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sumamed 1200 XL and other antibacterial drugs, Sumamed 1200 XL should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to Sumamed 1200 XL. Therapy with Sumamed 1200 XL may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.

How should I use Sumamed 1200 XL?

Use Sumamed 1200 XL drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Sumamed 1200 XL drops. Talk to your pharmacist if you have questions about this information.
  • Sumamed 1200 XL drops is for use in the eye only. Do not swallow it.
  • Wash your hands immediately before you use Sumamed 1200 XL drops.
  • To use Sumamed 1200 XL drops, turn the bottle upside down and shake once before each use. Remove the cap while the bottle is still upside down. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Gently squeeze the bottle to drop the medicine into the pouch, then gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
  • If a drop does not come out of the bottle when using your dose, repeat these steps.
  • To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
  • Do not wear contact lenses while you are using Sumamed 1200 XL drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
  • To clear up your infection completely, use Sumamed 1200 XL drops for the full course of treatment. Keep using it even if you feel better in a few days.
  • If you miss a dose of Sumamed 1200 XL drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Sumamed 1200 XL drops.

Uses of Sumamed 1200 XL in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications

Oral, IV:

Chancroid: Treatment of genital ulcer disease (in men) due to Haemophilus ducreyi (chancroid)

Chronic obstructive pulmonary disease, acute exacerbation: Treatment of acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD) due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae

Mycobacterium avium complex: Prevention of Mycobacterium avium complex (MAC) in patients with advanced HIV infection; treatment of disseminated MAC (in combination with ethambutol) in patients with advanced HIV infection

Otitis media, acute: Treatment of acute otitis media due to H. influenzae, M. catarrhalis, or S. pneumoniae

Pneumonia, community-acquired: Treatment of community-acquired pneumonia (CAP) due to Chlamydophila pneumoniae, H. influenzae, Legionella pneumophila, M. catarrhalis, Mycoplasma pneumoniae, or S. pneumoniae

Skin and skin structure infection, uncomplicated: Treatment of uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae

Streptococcal pharyngitis (group A): Treatment of pharyngitis/tonsillitis due to S. pyogenes as an alternative to first-line therapy

Urethritis/cervicitis: Treatment of urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae

Off Label Uses

Acne vulgaris

Data from controlled trials support the use of Sumamed 1200 XL in the treatment of acne vulgaris in adults with moderate to severe acne.

Based on the American Academy of Dermatology guidelines of care for the management of acne vulgaris, Sumamed 1200 XL, in combination with topical therapy, may be considered as a treatment option for moderate and severe acne and forms of inflammatory acne that are resistant to topical treatments. However, its use should be limited to patients who cannot receive a tetracycline (ie, pregnant women). Concomitant topical therapy with benzoyl peroxide or a retinoid should be administered with systemic antibiotic therapy (eg, Sumamed 1200 XL) and continued for maintenance after the antibiotic course is completed.

Babesiosis

Data from a prospective, nonblinded, randomized trial in patients with non-life-threatening babesiosis, support the use of Sumamed 1200 XL (in combination with atovaquone) for the treatment of this condition.

Based on the CDC Yellow Book, the ACG guideline for the diagnosis, treatment, and prevention of acute diarrheal infections in adults, and the IDSA practice guidelines for the diagnosis and management of infectious diarrhea, Sumamed 1200 XL is effective and recommended treatment for patients with travelers' diarrhea. Due to increased levels of resistance to fluoroquinolones, Sumamed 1200 XL may be a recommended first-line treatment, especially in regions with a high prevalence of Campylobacter (eg, Southeast Asia, India) or in geographical areas with suspected fluoroquinolone-resistant pathogens or enterotoxigenic Escherichia coli.

Sumamed 1200 XL description

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Each capsule contains Azithromycin dihydrate 262.05 mg equivalent to Sumamed 1200 XL base 250 mg. It also contains anhydrous lactose, maize starch, magnesium stearate and sodium lauryl sulfate as excipients. The capsule shell contains gelatin, titanium dioxide (E171) and up to 1,000 ppm sulfur dioxide.

Each tablet contains Azithromycin dihydrate 262.05 mg equivalent to Sumamed 1200 XL base 250 mg. It also contains pre-gelatinized starch, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate and sodium lauryl sulfate as excipients. The film-coating contains hydroxypropyl cellulose, triacetin and titanium dioxide (E171).

Each 5 mL of powder for oral suspension contains Azithromycin dihydrate 209.64 mg equivalent to Sumamed 1200 XL base 200 mg. It also contains sucrose (1.94 g/100 mg dose), anhydrous tribasic sodium phosphate, hydroxypropyl cellulose, xanthan gum, artificial cherry, creme de vanilla and banana flavors as excipients.

Each sachet contains Azithromycin dihydrate 100.16 mg equivalent to Sumamed 1200 XL base 100 mg. It also contains sucrose (1.85 g/Sumamed 1200 XL 100-mg dose), anhydrous tribasic sodium phosphate, hydroxypropyl cellulose, xanthan gum, artificial cherry, creme de vanilla and banana flavors as excipients. It also contains a dry powder which yields, when added to water, a white to off-white suspension, cherry/banana with a slight vanilla odor.

Each vial contains Azithromycin dihydrate 524.1 mg equivalent to Sumamed 1200 XL base 500 mg. It also contains anhydrous citric acid and sodium hydroxide as excipients. It is supplied in lyophilized form under a vacuum in a 10-mL vial for IV administration. Upon reconstitution, Sumamed 1200 XL powder yields a solution containing the equivalent of Sumamed 1200 XL 100 mg/mL.

Sumamed 1200 XL is 9-deoxy-9a-aza-9a-methyl-9a-homoerythromycin A. The molecular weight is 749.

Sumamed 1200 XL dosage

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Sumamed 1200 XL for oral suspension (single dose 1 g packet) can be taken with or without food after constitution. However, increased tolerability has been observed when tablets are taken with food.

Sumamed 1200 XL for oral suspension (single dose 1 g packet) is not for pediatric use. For pediatric suspension see the prescribing information for Sumamed 1200 XL (Sumamed 1200 XL for oral suspension) 100 mg/5 mL and 200 mg/5 mL bottles.

Directions for administration of Sumamed 1200 XL for oral suspension in the single dose packet (1 g): The entire contents of the packet should be mixed thoroughly with two ounces (approximately 60 mL) of water. Drink the entire contents immediately; add an additional two ounces of water, mix, and drink to ensure complete consumption of dosage. The single dose packet should not be used to administer doses other than 1000 mg of Sumamed 1200 XL.

Sexually Transmitted Diseases

The recommended dose of Sumamed 1200 XL for the treatment of non-gonococcal urethritis and cervicitis due to C. trachomatis is a single 1 gram (1000 mg) dose of Sumamed 1200 XL. This dose can be administered as one single dose packet (1 g).

Mycobacterial Infections

Prevention of Disseminated MAC Infections

The recommended dose of Sumamed 1200 XL for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of Sumamed 1200 XL may be combined with the approved dosage regimen of rifabutin.

Treatment of Disseminated MAC Infections

Sumamed 1200 XL should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of Sumamed 1200 XL plus ethambutol at the discretion of the physician or health care provider.

How supplied

Dosage Forms And Strengths

Sumamed 1200 XL 600 mg tablets (engraved on front with “PFIZER” and on back with “308”) are supplied as white, modified oval-shaped, film-coated tablets containing Sumamed 1200 XL dihydrate equivalent to 600 mg Sumamed 1200 XL. These are packaged in bottles of 30 tablets.

Sumamed 1200 XL for oral suspension 1000 mg/5 mL is supplied in single-dose packets containing Sumamed 1200 XL dihydrate equivalent to 1 gram of Sumamed 1200 XL.

Storage And Handling

Sumamed 1200 XL 600 mg tablets (engraved on front with “PFIZER” and on back with “308”) are supplied as white, modified oval-shaped, film-coated tablets containing Sumamed 1200 XL dihydrate equivalent to 600 mg Sumamed 1200 XL. These are packaged in bottles of 30 tablets. Sumamed 1200 XL tablets are supplied as follows:

Bottles of 30 NDC 0069-3080-30

Tablets should be stored at or below 30°C (86°F).

Sumamed 1200 XL for oral suspension is supplied in single-dose packets containing Sumamed 1200 XL dihydrate equivalent to 1 gram of Sumamed 1200 XL as follows:

Boxes of 10 single-dose packets (1 g) NDC 0069-3051-07

Boxes of 3 single-dose packets (1 g) NDC 0069-3051-75

Store single-dose packets between 5° and 30°C (41° and 86°F).

Distributed by: Pfizer Labs Division of Pfizer Inc., NY, NY 10017. Revised: Dec 2015

Sumamed 1200 XL interactions

See also:
What other drugs will affect Sumamed 1200 XL?

Antacids: In a pharmacokinetic study investigating the effects of simultaneous administration of antacid with Sumamed 1200 XL, no effect on overall bioavailability was seen, although peak serum concentrations were reduced by approximately 24%. In patients receiving both Sumamed 1200 XL and antacids, the drugs should not be taken simultaneously. Co-administration of Sumamed 1200 XL extended-release granules for oral suspension with a single dose of 20 mL co-magaldrox (aluminum hydroxide and magnesium hydroxide) did not affect the rate and extent of Sumamed 1200 XL absorption.

Cetirizine: In healthy volunteers, co-administration of a 5-day regimen of Sumamed 1200 XL with 20 mg cetirizine at steady-state resulted in no pharmacokinetic interaction and no significant changes in the QT interval.

Didanosine (Dideoxyinosine): Co-administration of 1,200 mg/day Sumamed 1200 XL with 400 mg/day didanosine in six HIV-positive subjects did not appear to affect the steady-state pharmacokinetics of didanosine as compared to placebo.

Digoxin: Concomitant administration of macrolide antibiotics, including Sumamed 1200 XL, with P-glycoprotein substrates such as digoxin, has been reported to result in increased serum levels of the P-glycoprotein substrate. Therefore, if Sumamed 1200 XL and P-glycoprotein substrates such as digoxin are administered concomitantly, the possibility of elevated serum digoxin concentrations should be considered. Clinical monitoring, and possibly serum digoxin levels, during treatment with Sumamed 1200 XL and after its discontinuation are necessary.

Ergot: There is a theoretical possibility of interaction between Sumamed 1200 XL and ergot derivatives.

Zidovudine: Single 1,000 mg doses and multiple 1,200 mg or 600 mg doses of Sumamed 1200 XL had little effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolite. However, administration of Sumamed 1200 XL increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of this finding is unclear, but it may be of benefit to patients.

Sumamed 1200 XL does not interact significantly with the hepatic cytochrome P450 system. It is not believed to undergo the pharmacokinetic drug interactions as seen with erythromycin and other macrolides. Hepatic cytochrome P450 induction or inactivation via cytochrome-metabolite complex does not occur with Sumamed 1200 XL.

Pharmacokinetic studies have been conducted between Sumamed 1200 XL and the following drugs known to undergo significant cytochrome P450-mediated metabolism.

Atorvastatin: Co-administration of atorvastatin (10 mg daily) and Sumamed 1200 XL (500 mg daily) did not alter the plasma concentrations of atorvastatin (based on a HMG CoA-reductase inhibition assay). However, post-marketing cases of rhabdomyolysis in patients receiving Sumamed 1200 XL with statins have been reported.

Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepine or its active metabolite in patients receiving concomitant Sumamed 1200 XL.

Cimetidine: In a pharmacokinetic study investigating the effects of a single dose of cimetidine, given 2 hours before Sumamed 1200 XL, on the pharmacokinetics of Sumamed 1200 XL, no alteration of Sumamed 1200 XL pharmacokinetics was seen.

Coumarin-Type

Oral Anticoagulants:

In a pharmacokinetic interaction study, Sumamed 1200 XL did not alter the anticoagulant effect of a single dose of 15 mg warfarin administered to healthy volunteers. There have been reports received in the post-marketing period of potentiated anticoagulation subsequent to co-administration of Sumamed 1200 XL and coumarin-type oral anticoagulants. Although a causal relationship has not been established, consideration should be given to the frequency of monitoring prothrombin time when Sumamed 1200 XL is used in patients receiving coumarin-type oral anticoagulants.

Cyclosporin: In a pharmacokinetic study with healthy volunteers who were administered a 500 mg/day oral dose of Sumamed 1200 XL for 3 days and were then administered a single 10 mg/kg oral dose of cyclosporin, the resulting cyclosporin Cmax and AUC0-5 were found to be significantly elevated. Consequently, caution should be exercised before considering concurrent administration of these drugs. If co-administration of these drugs is necessary, cyclosporin levels should be monitored and the dose adjusted accordingly.

Efavirenz: Co-administration of a single dose of 600 mg Sumamed 1200 XL and 400 mg efavirenz daily for 7 days did not result in any clinically significant pharmacokinetic interactions.

Fluconazole: Co-administration of a single dose of 1,200 mg Sumamed 1200 XL did not alter the pharmacokinetics of a single dose of 800 mg fluconazole. Total exposure and half-life of Sumamed 1200 XL were unchanged by the co-administration of fluconazole; however, a clinically insignificant decrease in Cmax (18%) of Sumamed 1200 XL was observed.

Indinavir: Co-administration of a single dose of 1,200 mg Sumamed 1200 XL had no statistically significant effect on the pharmacokinetics of indinavir administered as 800 mg three times daily for 5 days.

Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, Sumamed 1200 XL had no significant effect on the pharmacokinetics of methylprednisolone.

Midazolam: In healthy volunteers, co-administration of 500 mg/day Sumamed 1200 XL for 3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of a single dose of 15 mg midazolam.

Nelfinavir: Co-administration of Sumamed 1200 XL (1,200 mg) and nelfinavir at steady-state (750 mg three times daily) resulted in increased Sumamed 1200 XL concentrations. No clinically significant adverse effects were observed and no dose adjustment was required. Although no dosage adjustment of Sumamed 1200 XL is recommended when administered with nelfinavir, close monitoring for known side effects of Sumamed 1200 XL, such as liver enzyme abnormalities and hearing impairment, is warranted.

Rifabutin: Co-administration of Sumamed 1200 XL and rifabutin did not affect the serum concentrations of either drug.

Neutropenia was observed in subjects receiving concomitant treatment of Sumamed 1200 XL and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship to combination with Sumamed 1200 XL has not been established.

Sildenafil: In normal healthy male volunteers, there was no evidence of an effect of Sumamed 1200 XL (500 mg daily for 3 days) on the AUC and Cmax of sildenafil or its major circulating metabolite.

Terfenadine: Pharmacokinetic studies have reported no evidence of an interaction between Sumamed 1200 XL and terfenadine. There have been rare cases reported where the possibility of such an interaction could not be entirely excluded; however, there was no specific evidence that such an interaction had occurred.

Theophylline: There is no evidence of a clinically significant pharmacokinetic interaction when Sumamed 1200 XL and theophylline are co-administered to healthy volunteers.

Triazolam: In 14 healthy volunteers, co-administration of 500 mg Sumamed 1200 XL on Day 1 and 250 mg on Day 2 with 0.125 mg triazolam on Day 2 had no significant effect on any of the pharmacokinetic variables for triazolam compared to triazolam and placebo.

Trimethoprim/Sulfamethoxazole: Co-administration of trimethoprim/sulfamethoxazole DS (160 mg/800 mg) for 7 days with 1,200 mg Sumamed 1200 XL on Day 7 had no significant effect on peak concentrations, total exposure or urinary excretion of either trimethoprim or sulfamethoxazole. Sumamed 1200 XL serum concentrations were similar to those seen in other studies.

Incompatibilities: Not applicable.

Sumamed 1200 XL side effects

See also:
What are the possible side effects of Sumamed 1200 XL?

Clinical Trials Experience

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 practice.

Adults:

The data described below reflect exposure to Sumamed 1200 XL in 728 adult patients. All patients received a single 2 g oral dose of Sumamed 1200 XL. The population studied had community-acquired pneumonia and acute bacterial sinusitis.

In controlled clinical trials with Sumamed 1200 XL, the majority of the reported treatment-related adverse reactions were gastrointestinal in nature and mild to moderate in severity.

Overall, the most common treatment-related adverse reactions in adult patients receiving a single 2 g dose of Sumamed 1200 XL were diarrhea/loose stools (12%), nausea (4%), abdominal pain (3%), headache (1%), and vomiting (1%). The incidence of treatment-related gastrointestinal adverse reactions was 17% for Sumamed 1200 XL and 10% for pooled comparators.

Treatment-related adverse reactions following Sumamed 1200 XL treatment that occurred with a frequency of <1% included the following:

Cardiovascular: Palpitations, chest pain

Gastrointestinal: Constipation, dyspepsia, flatulence, gastritis, oral moniliasis

Genitourinary: Vaginitis

Nervous system: Dizziness, vertigo

General: Asthenia

Allergic: Rash, pruritus, urticaria

Special senses: Taste perversion

Pediatric Patients:

The data described below reflect exposure to Sumamed 1200 XL in 907 pediatric patients. The population was 3 months to 12 years of age. All patients received a single 60 mg/kg oral dose of Sumamed 1200 XL.

As in adults, the most common treatment-related adverse reactions in pediatric subjects were gastrointestinal in nature. The pediatric subjects all received a single 60 mg/kg dose (equivalent to 27 mg/lb) of Sumamed 1200 XL.

In a trial with 450 pediatric subjects (ages 3 months to 48 months), vomiting (11%), diarrhea (10%) loose stools (9%), and abdominal pain (2%) were the most frequently reported treatment-related gastrointestinal adverse reactions. Many treatment related gastrointestinal adverse reactions with an incidence greater than 1% began on the day of dosing in these subjects [43% (68/160)] and most [53% (84/160)] resolved within 48 hr of onset. Treatment-related adverse events that were not gastrointestinal, occurring with a frequency ≥ 1% were: rash (5%), anorexia (2%), fever (2%), and dermatitis (2%).

In a second trial of 337 pediatric subjects, ages 2 years to 12 years, the most frequently reported treatment-related adverse reactions also included vomiting (14%), diarrhea (7%), loose stools (2%), nausea (4%) and abdominal pain (4%).

A third trial investigated the tolerability of two different concentrations of Sumamed 1200 XL oral suspension in 120 pediatric subjects (ages 3 months to 48 months), all of whom were treated with Sumamed 1200 XL. The study evaluated the hypothesis that a more dilute, less viscous formulation (the recommended 27 mg/mL concentration of Sumamed 1200 XL) is less likely to induce vomiting in young children than a more concentrated suspension used in other pediatric studies. The vomiting rate for subjects taking the dilute concentration Sumamed 1200 XL was 3% (2/61). The rate was numerically lower but not statistically different from the vomiting for the more concentrated suspension Across both treatment arms, the only treatment-related adverse events with a frequency of ≥ 1% were vomiting (6%, 7/120) and diarrhea (2%, 2/120).

Treatment-related adverse reactions with a frequency of < 1% following Sumamed 1200 XL treatment in all 907 pediatric subjects in the Phase 3 studies were:

Body as a whole: Chills, fever, flu syndrome, headache;

Digestive: Abnormal stools, constipation, dyspepsia, flatulence, gastritis, gastrointestinal disorder, hepatitis;

Hematologic and lymphatic: Leukopenia;

Nervous system: Agitation, emotional liability, hostility, hyperkinesia, insomnia, irritability, paresthesia, Somnolence;

Respiratory: Asthma, bronchitis, cough, dyspnea, pharyngitis, rhinitis;

Skin and appendages: Dermatitis, fungal dermatitis, maculopapular rash, pruritus, urticaria;

Special senses: Otitis media, taste perversion;

Urogenital: Dysuria.

Postmarketing Experience with Other Sumamed 1200 XL Products

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.

Adverse events reported with Sumamed 1200 XL immediate release formulations during the postmarketing period for which a causal relationship may not be established include:

Allergic: Arthralgia, edema, urticaria and angioedema

Cardiovascular: Palpitations and arrhythmias including ventricular tachycardia and hypotension

There have been reports of QT prolongation and torsades de pointes.

Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and rare reports of tongue discoloration

General: Asthenia, paresthesia, fatigue, malaise and anaphylaxis

Genitourinary: Interstitial nephritis, acute renal failure and vaginitis

Hematopoietic: Thrombocytopenia, mild neutropenia

Liver/biliary: Adverse reactions related to hepatic dysfunction have been reported in postmarketing experience with Sumamed 1200 XL.

Nervous system: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope

Psychiatric: Aggressive reaction and anxiety

Skin/appendages: Pruritus, rash, photosensitivity, serious skin reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS.

Special senses: Hearing disturbances including hearing loss, deafness and/or tinnitus and reports of taste/smell perversion and/or loss

Laboratory Abnormalities

In subjects with normal baseline values, the following clinically significant laboratory abnormalities (irrespective of drug relationship) were reported in Sumamed 1200 XL clinical trials in adults and pediatric patients:

Adults:

Laboratory abnormalities with an incidence of greater than or equal to 1%: reduced lymphocytes and increased eosinophils; reduced bicarbonate. Laboratory abnormalities with an incidence of less than 1%: leukopenia, neutropenia, elevated bilirubin, AST, ALT, BUN, creatinine, alterations in potassium. Where follow-up was provided, changes in laboratory tests appeared to be reversible.

Pediatric Patients:

Laboratory abnormalities with an incidence of greater than or equal to 1%: elevated eosinophils, BUN, and potassium; decreased lymphocytes; and alterations in neutrophils; with an incidence of less than 1%: elevated SGOT, SGPT and creatinine; decreased potassium; and alterations in sodium and glucose.

Sumamed 1200 XL contraindications

See also:
What is the most important information I should know about Sumamed 1200 XL?

You should not use this medication if you have ever had jaundice or liver problems caused by taking Sumamed 1200 XL. You should not use Sumamed 1200 XL if you are allergic to it or to similar drugs such as erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), clarithromycin (Biaxin), telithromycin (Ketek), or troleandomycin (Tao).

There are many other medicines that can interact with Sumamed 1200 XL. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Take this medicine 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. Sumamed 1200 XL will not treat a viral infection such as the common cold or flu.

Avoid taking an antacid within 2 hours before or after you take Sumamed 1200 XL. Some antacids can make it harder for your body to absorb Sumamed 1200 XL.



Active ingredient matches for Sumamed 1200 XL:

Azithromycin in Serbia.


List of Sumamed 1200 XL substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Capsule; Oral; Azithromycin Dihydrate 250 mg
Tablet, Film-Coated; Oral; Azithromycin Dihydrate 500 mg
Capsules; Oral; Azithromycin Dihydrate 250 mg
Tablets, Film-Coated; Oral; Azithromycin Dihydrate 500 mg
Capsule; Oral; Azithromycin Dihydrate 250 mg
Capsules; Oral; Azithromycin Dihydrate 250 mg
Superazi 250mg TAB / 10 (Auspi Medicaments)$ 0.21
Superazi 500mg TAB / 6 (Auspi Medicaments)$ 2.33
250 mg x 10's (Auspi Medicaments)$ 0.21
500 mg x 6's (Auspi Medicaments)$ 2.33
Superazi 250 mg Tablet (Auspi Medicaments)$ 0.21
Superazi 500 mg Tablet (Auspi Medicaments)$ 0.39
SUPERAZI tab 250 mg x 10's (Auspi Medicaments)$ 2.10
SUPERAZI tab 500 mg x 6's (Auspi Medicaments)$ 2.33
Suprazi 500 mg Tablet (Tishcon Pharmed)$ 0.34
SUPRAZI 100MG SUSPENSION 1 bottle / 15 ML suspension each (Tishcon Pharmed)$ 0.39
SUPRAZI 200MG SUSPENSION 1 bottle / 15 ML suspension each (Tishcon Pharmed)$ 0.53
SUPRAZI 250MG TABLET 1 strip / 6 tablets each (Tishcon Pharmed)$ 0.90
SUPRAZI 500MG TABLET 1 strip / 3 tablets each (Tishcon Pharmed)$ 0.98
Suprazi 100mg Suspension (Tishcon Pharmed)$ 0.39
Suprazi 200mg Suspension (Tishcon Pharmed)$ 0.53
Suprazi 250mg Tablet (Tishcon Pharmed)$ 0.15
Suprazi 500mg Tablet (Tishcon Pharmed)$ 0.33
Suprozith 15 ml Suspension (Athens Labs Ltd.)$ 0.22
Suprozith 500 mg Tablet (Athens Labs Ltd.)$ 0.40
SUPROZITH 250MG SUSPENSION 1 bottle / 15 ML suspension each (Athens Labs Ltd.)$ 0.67
SUPROZITH 500MG TABLET 1 strip / 3 tablets each (Athens Labs Ltd.)$ 1.08
Suprozith 250mg Suspension (Athens Labs Ltd.)$ 0.67
Suprozith 500mg Tablet (Athens Labs Ltd.)$ 0.30
SVIZTHROCIN 250 MG TABLET 1 strip / 10 tablets each (Maneesh Pharmaceuticals Ltd)$ 0.24
Svizthrocin 250mg Tablet (Maneesh Pharmaceuticals Ltd)$ 0.02
Sweazi 250mg TAB / 60 (BMW Pharmaco India Pvt Ltd)$ 12.38
Sweazi 500mg TAB / 30 (BMW Pharmaco India Pvt Ltd)$ 11.90
250 mg x 60's (BMW Pharmaco India Pvt Ltd)$ 12.38
500 mg x 30's (BMW Pharmaco India Pvt Ltd)$ 11.90
Sweazi 250 mg Tablet (BMW Pharmaco India Pvt Ltd)$ 0.21
Sweazi 500 mg Tablet (BMW Pharmaco India Pvt Ltd)$ 0.41
SWEAZI tab 250 mg x 6's (BMW Pharmaco India Pvt Ltd)$ 1.33
SWEAZI tab 500 mg x 3's (BMW Pharmaco India Pvt Ltd)$ 1.33

References

  1. DailyMed. "AZITHROMYCIN: 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. PubChem. "azithromycin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "azithromycin". http://www.drugbank.ca/drugs/DB00207 (accessed September 17, 2018).

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