pedmark
Pedmark (Sodium Thiosulfate) is a medication used to treat Tinea Versicolor, Arsenic Poisoning.
Sodium Thiosulfate · by Fennec Pharms Inc
Available as a generic: Sodium Thiosulfate
Key facts
- Active ingredient
- Sodium Thiosulfate
- Form
- Injectable
- Strength
- Sodium Thiosulfate 12.5GM/100ML (125MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- tinea versicolor, arsenic poisoning
- Manufacturer
- Fennec Pharms Inc
- FDA application
- NDA212937
What is Pedmark?
From the FDA label:Sodium thiosulfate anhydrous is an inorganic salt with a molecular formula of Na 2 S 2 O 3 and a molecular weight of 158.11 g/mol. The structural formula is: It is a white to off-white crystalline solid that is soluble in water, but insoluble in alcohol. The aqueous solution has a pH ranging from 6.5 to 8.0. PEDMARK (sodium thiosulfate injection) is a sterile, preservative-free, clear, colorless solution in a single-dose vial for intravenous use with a pH between 7 and 9. Each vial contains the equivalent of 12.5 grams of sodium thiosulfate pentahydrate (provided as sodium thiosulfate anhydrous 8 grams) in 100 mL solution (125 mg/mL). Each mL contains the equivalent of 125 mg of sodium thiosulfate pentahydrate (provided as sodium thiosulfate anhydrous 80 mg) and 0.25 mg boric acid. Sodium hydroxide and hydrochloric acid may have been used for pH adjustment. Chemical Structure
How to use
PEDMARK is not substitutable with other sodium thiosulfate products. ( 2 ) The recommended dose of PEDMARK is based on surface area according to actual body weight. Administer PEDMARK as an intravenous infusion over 15 minutes starting 6 hours after completion of cisplatin infusion. For multiday cisplatin regimens, administer PEDMARK 6 hours after each cisplatin infusion but at least 10 hours before the next cisplatin infusion. Do not start PEDMARK if less than 10 hours before starting the next cisplatin infusion ( 2 ) Actual Body Weight PEDMARK Dose Less than 5 kg 10 g/m 2 5 to 10 kg 15 g/m 2 Greater than 10 kg 20 g/m 2 2.1 Important Dosing Information PEDMARK is not substitutable with other sodium thiosulfate products. Ensure serum sodium level is within normal range prior to initiating PEDMARK [see Warnings and Precautions (5.2) ] . 2.2 Recommended Dosage and Administration The recommended dose of PEDMARK is based on surface area according to actual body weight as summarized in Table 1. Table 1. Recommended Dose for PEDMARK Actual Body Weight PEDMARK Dose Less than 5 kg 10 g/m 2 5 to 10 kg 15 g/m 2 Greater than 10 kg 20 g/m 2 Administer PEDMARK as an intravenous infusion over 15 minutes, following cisplatin infusions that are 1 to 6 hours in duration [see Indications and Usage (1) ] . Infuse PEDMARK as described below to minimize the potential interference with the…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Hypernatremia and Hypokalemia [see Warnings and Precautions (5.2) ] Nausea and Vomiting [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥ 25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 are vomiting, nausea, decreased hemoglobin, and hypernatremia. ( 6 ) Most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 is hypokalemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fennec Pharmaceuticals, Inc. at 1-833-336-6321, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. SIOPEL 6 The safety of PEDMARK was evaluated in SIOPEL 6 [see Clinical Studies (14) ]. Patients received cisplatin-based chemotherapy with or without PEDMARK administered at a dose of 10 g/m 2 , 15 g/m 2 , or 20 g/m 2 (depending on body weight) as an intravenous infusion over 15 minutes starting 6 hours after completion of each cisplatin infusion. Patients…
Warnings
Important safety information
Hypersensitivity : Immediately discontinue PEDMARK and institute appropriate care. Administer premedications before each subsequent dose. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions. ( 5.1 ) Hypernatremia and Hypokalemia : PEDMARK is not indicated for use in pediatric patients less than 1 month of age. Monitor serum sodium and potassium at baseline and as clinically indicated. Withhold PEDMARK in patients with serum sodium greater than 145 mmol/L ( 5.2 ) Nausea and Vomiting : Administer antiemetics prior to each PEDMARK administration. ( 5.3 ) 5.1 Hypersensitivity Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials [see Adverse Reactions (6.1) ]. PEDMARK is contraindicated in patients with a history of severe hypersensitivity to sodium thiosulfate or its components [see Contraindications (4) ]. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs [see Dosage and Administration (2.4) ] . Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK [see Dosage and Administration (2.3) ] . PEDMARK may contain sodium sulfite. Sulfite exposure can cause hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes, in patients with sulfite sensitivity. The overall prevalence of sulfite sensitivity in the general population is unknown; sulfite sensitivity is seen more frequently in people with asthma compared to people without asthma. 5.2 Hypernatremia and Hypokalemia At the recommended dosage of PEDMARK, a 20 g/m 2 dose delivers a sodium load of 162 mmol/m 2 , a 15 g/m 2 dose delivers a sodium load of 121 mmol/m 2 and a 10 g/m 2 dose delivers a sodium load of 81 mmol/m 2 . Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% [see Adverse Reactions (6.1) ]. Pediatric patients younger than 1 month have less well-developed sodium homeostasis compared to other pediatric patients. PEDMARK is not indicated and not recommended for use in pediatric patients younger than 1 month of age. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Do not initiate PEDMARK infusions in patients with baseline serum sodium greater than 145 mmol/L [see Clinical Pharmacology (12.2) , Dosage and Administration (2.3) ] . Withhold PEDMARK in patients with serum sodium greater than 145 mmol/L [see Clinical Pharmacology (12.2) , Dosage and Administration (2.4) ] . Monitor for signs and symptoms of hypernatremia and hypokalemia. Provide supportive care and supplementation as appropriate. 5.3 Nausea and Vomiting Nausea occurred in 8% to 40% of patients in clinical trials, with Grade 3 or 4 in 3.8 to 8%. Vomiting occurred in 7% to 85% of patients in clinical trials, with Grade 3 or 4 in 7% to 8% [see Adverse Reactions (6.1) ]. Administer antiemetics prior to each PEDMARK administration [see Dosage and Administration (2.3) ] . Provide additional antiemetics and supportive care as appropriate.
Who should not take Pedmark
PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components [see Warnings and Precautions (5.1) ] . History of severe hypersensitivity to sodium thiosulfate or any components. ( 4 )
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Pedmark treat?
- Pedmark (Sodium Thiosulfate) may be used to treat tinea versicolor, arsenic poisoning, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Pedmark?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Pedmark. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Pedmark?
- Pedmark is marketed by Fennec Pharms Inc. You can see Fennec Pharms Inc's full profile, rating, and other products on pharmaranks.
- Is Pedmark a brand-name or generic drug?
- Pedmark is a brand-name product with the active ingredient Sodium Thiosulfate. Lower-cost generic equivalents containing Sodium Thiosulfate are available — ask your pharmacist.
- Is Pedmark available over the counter?
- No. Pedmark is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Pedmark come in?
- Pedmark is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Pedmark FDA-registered?
- Pedmark is on record with the U.S. FDA under application number NDA212937. You can verify this on its official FDA label.
- Is Pedmark safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Pedmark. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Pedmark?
- Pedmark's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Hypernatremia and Hypokalemia [see Warnings and Precautions (5.2) ] Nausea and Vomiting [see Warnings and Precautions (5.3) ] Most common adverse rea… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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