Tresaderm Side effects

• Side effects of Dexamethasone (Tresaderm) in details
• Dexamethasone (Tresaderm) contraindications
• Side effects of Neomycin sulfate (Tresaderm) in details
• Neomycin sulfate (Tresaderm) contraindications
• Side effects of Thiabendazole solution (Tresaderm) in details
• Thiabendazole solution (Tresaderm) contraindications
• Tresaderm reviews

Consists of dexamethasone, neomycin sulfate, thiabendazole solution

What are the possible side effects of Dexamethasone (Tresaderm)?

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

Call your doctor at once if you have:

• muscle tightness, weakness, or limp feeling;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• severe depression, unusual thoughts or behavior;

• a seizure (convulsions);

• bloody or tarry stools, coughing up blood;

• fast or slow heart rate, weak pulse;

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;

• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling; or

• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Dexamethasone (Tresaderm) can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Dexamethasone (Tresaderm).

Common side effects may include:

• fluid retention (swelling in your hands or ankles);

• increased appetite;

• mood changes, trouble sleeping;

• skin rash, bruising or discoloration;

• acne, increased sweating, increased hair growth;

• headache, dizziness;

• nausea, vomiting, upset stomach;

• changes in your menstrual periods; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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.

See also:

Dexamethasone (Tresaderm) side effects (in more detail)

Side effects of Dexamethasone (Tresaderm) in details

Clinical Studies Experience: Treatment of Macular Edema: Clinical Studies 206207‐008 and 206207‐009 (Initial 6‐month Treatment Period): The clinical safety of Dexamethasone (Tresaderm) was assessed in 2 phase 3 randomized, double‐masked, sham-controlled studies in patients with macular edema following BRVO or CRVO. In both studies, a total of 421 patients were randomized and received Dexamethasone (Tresaderm) and 423 received sham.

The most frequently reported adverse reactions considered to be related to the intravitreal injection procedure rather than the Dexamethasone (Tresaderm) implant, included vitreous hemorrhage and conjunctival edema.

Intraocular Pressure in the Initial 6‐month Treatment Period of Studies 008 and 009: See Table 4.

The proportion of patients with increases from baseline IOP ≥10 mmHg in the study eye was significantly greater with Dexamethasone (Tresaderm) compared to sham at days 7, 30, 60, and 90. At day 180, there were no significant differences between Dexamethasone (Tresaderm) and sham.

The proportion of patients experiencing increased IOP with Dexamethasone (Tresaderm) peaked at day 60 and returned to baseline levels by day 180. Elevations of IOP either did not require treatment or were managed with topical IOP‐lowering medications in the vast majority of patients. During the initial treatment period, only 0.7% (3/421) of the patients who received Dexamethasone (Tresaderm) required laser or surgical procedures for management of elevated IOP in the study eye compared with 0.2% (1/423) with sham.

Systemic effects with Dexamethasone (Tresaderm) would be expected to be negligible due to low systemic levels (below the lower level of quantitation). The adverse event profile for BRVO patients was generally similar to that observed for CRVO patients, and to the overall population. The overall incidence of adverse events was higher for the subgroup of patients with CRVO, which is consistent with the nature of the disease as patients with CRVO are more likely to develop ocular adverse events than patients with BRVO, even when not treated.

Clinical Studies 206207‐008 and 206207‐009 (6‐month Open‐label Extension): The clinical safety of Dexamethasone (Tresaderm) was further assessed in a 6‐month open‐label (OL) extension of both phase 3 studies. Patients were eligible for re‐treatment if the BCVA was <84 letters or retinal thickness was >250 mcg in the central 1 mm macular subfield and the investigator considered that the procedure would not put the patient at significant risk. The re‐treated population consisted of patients who received Dexamethasone (Tresaderm), or sham as their 1st injection, completed the initial treatment period at day 180, and then received Dexamethasone (Tresaderm) as their 2nd injection. A total of 997 patients received the Dexamethasone (Tresaderm) injection in the open‐label phase of both studies.

For those events reported at a rate of ≥1%, the types of events and their incidence following the 2nd injection were similar to those seen following the 1st injection with the exception of subcapsular cataract which were higher in patients who had received Dexamethasone (Tresaderm) as their 1st injection followed by Dexamethasone (Tresaderm) as the 2nd injection. More specifically, subcapsular cataracts in the study eye were notably more common in the Dexamethasone (Tresaderm)/Dexamethasone (Tresaderm) group (12.9%) compared to either sham/Dexamethasone (Tresaderm) (3.4%).

For events reported in ≤1% of patients, mostly in only 1 or 2 patients per group, some differences between the 1st and 2nd injection were seen. Review of these differences does not suggest a safety signal associated with repeat treatments.

The incidence of IOP increased was comparable between patients receiving either 1 or 2 doses of Dexamethasone (Tresaderm).

Treatment of Uveitis: Clinical Study 206207‐014: The clinical safety of Dexamethasone (Tresaderm) was assessed in a multicenter, masked, and randomized, 26‐week phase 3 study in the treatment of non‐infectious uveitis affecting the posterior segment of the eye. A total of 76 patients were treated with Dexamethasone (Tresaderm) and 75 were treated with sham.

Intraocular Pressure in Study ‐014: As shown in Table 7, there were no clinically meaningful differences in the proportions of Dexamethasone (Tresaderm) and sham patients who experienced IOP at ≥25 mmHg or ≥35 mmHg in the study eye, at any visit. At week 26, no Dexamethasone (Tresaderm) patients and 3 sham patients had an IOP ≥25 mmHg; no patients had an IOP ≥35 mmHg.

Table 8 shows the proportion of patients with increases from baseline IOP ≥10 mmHg in the study eye was similar between Dexamethasone (Tresaderm) and sham, except at week 8 where significantly higher percentages were observed with Dexamethasone (Tresaderm) (9.6%) compared to sham (0%), p=0.013. At week 26, only 1 Dexamethasone (Tresaderm) patient and 2 sham patients showed an increase from baseline IOP ≥10 mmHg.

The proportion of Dexamethasone (Tresaderm)‐treated patients with increased IOP (≥25 mmHg) peaked at week 3 and returned to baseline by week 26. During the treatment period, no patients required incisional surgery for glaucoma. Three patients required laser iridotomies in the study eye for the treatment of pupillary block, iris bombe, and raised IOP.

Post-Marketing Experience: The following adverse reactions have been identified during post-marketing use of Dexamethasone (Tresaderm) in clinical practice. Because post-marketing reporting of these reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions. The reactions have been chosen for inclusion due to a combination of the frequency of reporting and/or possible causal connection to Dexamethasone (Tresaderm).

Eye Disorders: Endophthalmitis: Hypotony of eye (associated with vitreous leakage due to injection), retinal detachment.

General Disorders and Administration Site Conditions: Complication of device insertion (implant misplacement), device dislocation with or without corneal edema.

What is the most important information I should know about Dexamethasone (Tresaderm)?

• Dexamethasone (Tresaderm) may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Tell your doctor or dentist that you take Dexamethasone (Tresaderm) before you receive any medical or dental care, emergency care, or surgery.
• Dexamethasone (Tresaderm) may cause an elevation in blood pressure, salt and water retention, and increased potassium loss. You may need to restrict the use of salt and take a calcium supplement.
• Dexamethasone (Tresaderm) can cause calcium loss and promote the development of osteoporosis. Take adequate calcium and vitamin D supplements.
• Diabetes patients -- Dexamethasone (Tresaderm) may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including may be performed while you use Dexamethasone (Tresaderm). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Dexamethasone (Tresaderm) in CHILDREN; they may be more sensitive to its effects.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Dexamethasone (Tresaderm).
• PREGNANCY and BREAST-FEEDING: It is not known if Dexamethasone (Tresaderm) can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dexamethasone (Tresaderm) while you are pregnant. Dexamethasone (Tresaderm) is found in breast milk. Do not breast-feed while taking Dexamethasone (Tresaderm).

Dexamethasone (Tresaderm) contraindications

You should not use this medication if you are allergic to Dexamethasone (Tresaderm), or if you have a fungal infection anywhere in your body.

Before taking Dexamethasone (Tresaderm), tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are taking Dexamethasone (Tresaderm). Vaccines may not work as well while you are taking a steroid.

Do not stop using Dexamethasone (Tresaderm) suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Wear a medical alert tag or carry an ID card stating that you take Dexamethasone (Tresaderm). Any medical care provider who treats you should know that you are using a steroid.

What are the possible side effects of Neomycin sulfate (Tresaderm)?

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

Call your doctor at once if you have a serious side effect such as:

• hearing problems, ringing in your ears, or a feeling of fullness in the ears;
• spinning sensation, nausea, feeling like you might pass out;
• loss of balance or coordination, trouble walking;
• numbness or tingly feeling under your skin;
• muscle twitching, seizure (convulsions);
• urinating less than usual or not at all;
• drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
• swelling, weight gain, feeling short of breath;
• weak or shallow breathing; or
• severe stomach cramps, diarrhea that is watery or bloody.

Less serious side effects may include:

• mild nausea, vomiting; or
• mild diarrhea.

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 Neomycin sulfate (Tresaderm) in details

The most common adverse reactions to oral Neomycin sulfate (Tresaderm) are nausea, vomiting and diarrhea. The "Malabsorption Syndrome" characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity and neuromuscular blockage have been reported.

What is the most important information I should know about Neomycin sulfate (Tresaderm)?

You should not take this medicine if you are allergic to Neomycin sulfate (Tresaderm) or similar antibiotics such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

You should not take Neomycin sulfate (Tresaderm) if you have ulcerative colitis, Crohn's disease, a blockage in your intestines, or other inflammatory bowel disease.

Do not use Neomycin sulfate (Tresaderm) if you are pregnant. It could harm the unborn baby.

Before you take Neomycin sulfate (Tresaderm), tell your doctor if you have kidney disease, myasthenia gravis, or Parkinson's disease.

Never take Neomycin sulfate (Tresaderm) in larger amounts than recommended, or for longer than 2 weeks. High doses or long-term use of Neomycin sulfate (Tresaderm) can cause serious kidney problems, or hearing loss that may not be reversible. The longer you take Neomycin sulfate (Tresaderm), the more likely you are to develop these serious side effects.

To be sure this medication is not causing harmful effects, your kidney function, and your nerve and muscle function will need to be tested often. You may also need hearing tests. Neomycin sulfate (Tresaderm) can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood or urine tests.

Neomycin sulfate (Tresaderm) can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using Neomycin sulfate (Tresaderm), tell your doctor about all other medicines you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

If you are being treated for hepatic coma, avoid eating foods that are high in protein. Follow your doctor's instructions about any other restrictions on food, beverages, or activity.

Neomycin sulfate (Tresaderm) contraindications

Neomycin sulfate (Tresaderm) oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.

Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to Neomycin sulfate (Tresaderm).

Neomycin sulfate (Tresaderm) oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of Neomycin sulfate (Tresaderm).

What are the possible side effects of Thiabendazole solution (Tresaderm)?

Stop taking Thiabendazole solution (Tresaderm) and seek emergency medical attention if you experience an allergic reaction (swelling of the lips, tongue, or face; shortness of breath; closing of the throat; or hives).

Rarely, other serious side effects can occur. Stop taking Thiabendazole solution (Tresaderm) and contact your doctor if you experience

• seizures;

• behavior or personality changes;

• skin rash;

• vision changes; or

• yellowing of the skin or eyes.

Other, less serious side effects may be more likely to occur. Continue to take Thiabendazole solution (Tresaderm) and talk to your doctor if you experience

• dizziness, drowsiness, or headache;

• numbness;

• nausea, vomiting, diarrhea, upset stomach, or decreased appetite;

• unusual urine odor;

• fever or chills;

• ringing in the ears;

• blurred vision or dryness of the eyes; or

• appearance of live worms in the mouth or nose.

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 Thiabendazole solution (Tresaderm) in details

Applies to Thiabendazole solution (Tresaderm): suspension, tablet

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Appetite loss; bad urine odor; diarrhea; dizziness; drowsiness; dry eyes; giddiness; headache; indigestion; irritability; nausea; sensation of floating; stomach upset or pain; tiredness; vomiting; weakness; worms in mouth or nose.

Seek medical attention right away if any of these SEVERE side effects occur while taking Thiabendazole solution (Tresaderm):

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; blurred vision; change in vision; chills; collapse; confusion; dark urine; depression; enlarged lymph nodes; flushing; hoarseness; increased thirst or urination; loss of coordination; numbness; red, swollen, or blistered skin; ringing in the ears; seizures; severe stomach pain; sore throat or fever; strange feeling in your eyes; uncontrolled urination; vision tinged yellow; yellowing of the skin or eyes.

What is the most important information I should know about Thiabendazole solution (Tresaderm)?

• Thiabendazole solution (Tresaderm) may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Thiabendazole solution (Tresaderm). Using Thiabendazole solution (Tresaderm) alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Strict hygiene is essential to prevent reinfection. To prevent getting this infection again, disinfect toilet facilities daily and change and wash underwear, bed linens, towels, and pajamas daily.
• Pinworm infections are easily spread to others. If one family member has a pinworm infection, all family members in close contact with the patient should be treated. This decreases the chance of spreading the infection.
• Do not use Thiabendazole solution (Tresaderm) to prevent worm infestations.
• Thiabendazole solution (Tresaderm) may cause high blood sugar (eg, thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, fruity breath odor). If these symptoms occur, tell your doctor immediately.
• LAB TESTS, including liver function tests, may be performed to monitor your progress. Be sure to keep all doctor and lab appointments.
• Use Thiabendazole solution (Tresaderm) with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Thiabendazole solution (Tresaderm) with extreme caution in CHILDREN younger than 4 years of age or who weigh less than 30 pounds (13.6 kg). Safety and effectiveness in these age and weight groups have not been established.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Thiabendazole solution (Tresaderm) during pregnancy. It is unknown if Thiabendazole solution (Tresaderm) is excreted in breast milk. Do not breast-feed while taking Thiabendazole solution (Tresaderm).

Thiabendazole solution (Tresaderm) contraindications

Hypersensitivity to this product.

Thiabendazole solution (Tresaderm) is contraindicated as prophylactic treatment for pinworm infestation.

References

1. DailyMed. "THIABENDAZOLE: 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. DailyMed. "DEXAMETHASONE: 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).
3. DailyMed. "HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE: 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).

Reviews

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