Sumamed Side effects

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What are the possible side effects of Sumamed?

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

In rare cases, Sumamed may cause a severe skin reaction that can be fatal if it spreads to other parts of the body. Seek medical treatment if you have a new or worsening skin rash with fever, swollen glands, flu symptoms, or severe tingling or numbness.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

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

  • severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Older adults may be more likely to have side effects on heart rhythm, including a life-threatening fast heart rate.

Common Sumamed side effects may include:

  • diarrhea;

  • nausea, vomiting, stomach pain; or

  • headache.

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 Sumamed 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 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 in 728 adult patients. All patients received a single 2 g oral dose of Sumamed. The population studied had community-acquired pneumonia and acute bacterial sinusitis.

In controlled clinical trials with Sumamed, 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 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 and 10% for pooled comparators.

Treatment-related adverse reactions following Sumamed 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 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.

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.

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 oral suspension in 120 pediatric subjects (ages 3 months to 48 months), all of whom were treated with Sumamed. The study evaluated the hypothesis that a more dilute, less viscous formulation (the recommended 27 mg/mL concentration of Sumamed) 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 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 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 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 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.

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 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.

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

  • Sumamed tablets may cause drowsiness, dizziness, blurred vision, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Sumamed tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Sumamed tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Sumamed tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody or watery stools occur. Do not treat diarrhea without first checking with your doctor.
  • Tell your doctor or dentist that you take Sumamed tablets before you receive any medical or dental care, emergency care, or surgery.
  • Severe and sometimes fatal liver problems have been reported with the use of Sumamed tablets. Contact your doctor immediately if you develop symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite; unusual itching). Discuss any questions or concerns with your doctor.
  • Long-term or repeated use of Sumamed tablets may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
  • Be sure to use Sumamed tablets for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • Sumamed tablets only works against bacteria; it does not treat viral infections (eg, the common cold).
  • Use Sumamed tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially irregular heartbeat.
  • Sumamed tablets should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sumamed tablets while you are pregnant. It is not known if Sumamed tablets is found in breast milk. If you are or will be breast-feeding while you take Sumamed tablets, check with your doctor. Discuss any possible risks to your baby.

Sumamed 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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You should not use this medication if you have ever had jaundice or liver problems caused by taking Sumamed. You should not use Sumamed 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. 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 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. Some antacids can make it harder for your body to absorb Sumamed.


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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. European Chemicals Agency - ECHA. "2R,3R,4R,5R,8R,10R,11R,13S,14R)-11-[(2S,3R,4S,6R)-4-dimethylamino-3-hydroxy-6-methyl-oxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2S,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyl-oxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-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).
  3. HSDB. "AZITHROMYCIN". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Sumamed 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 Sumamed. 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.

User reports

8 consumers reported side effects

Did you experience side effects while taking Sumamed drug?
According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Sumamed drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
Users%
It has side effects6
75.0%
No side effects2
25.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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