Thyrotox Recall

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Sildenafil injection is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil injection was added to background epoprostenol therapy [see Clinical Studies (14)].

Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).


There is currently no drug history available for this drug.

Other Information

Sildenafil injection, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction.

Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula:
Sildenafil Citrate Chemical Structure
Sildenafil citrate USP is a white or almost white slightly hygroscopic crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.

Sildenafil injection is supplied as a clear, colorless, sterile, ready to use solution in a single-use vial containing 10 mg/12.5 mL of sildenafil. Each mL of solution contains 1.124 mg sildenafil citrate USP equivalent to 0.8 mg sildenafil, 50.5 mg dextrose and water for injection.

Thyrotox Manufacturers

  • Apotheca Company
    Thyrotox (Chondrus Crispus, Fucus Vesiculosus, Thyroidinum, Belladonna, Calcarea Carbonica, Conium Maculatum, Iodium, Kali Carbonicum. Phosphorus, Pulsatilla, Silicea,) Liquid [Apotheca Company]
  • Bioactive Nutritional, Inc.
    Thyrotox (Chondrus Crispus, Fucus Vesiculosus, Thyroidinum, Belladonna, Calcarea Carbonica, Conium Maculatum) Liquid [Bioactive Nutritional, Inc.]

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